http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 24 Jul 2026 06:26:16 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html <p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Gilead Sciences' (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy and whose tumors express PD-L1 with a combined positive score of CPS ≥10.</p> <p>A final decision from the European Commission is anticipated later in 2026. The recommendation is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed that the combination reduced the risk of disease http://www.streetinsider.com/FDA/EU+panel+backs+Gilead%27s+Trodelvy+plus+Keytruda+for+breast+cancer/26810193.html Fri, 24 Jul 2026 06:26:16 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Press+Releases/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661 http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html <p class="bwalignc"> <b><i>– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union –</i></b> </p><p class="bwalignc"> <b><i>– ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death –</i></b> </p> <p> FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or http://www.streetinsider.com/Business+Wire/CHMP+Recommends+Gilead%E2%80%99s+Trodelvy%C2%AE+Plus+Keytruda%C2%AE+in+PD-%28L%291-Positive+First-Line+Metastatic+Triple-Negative+Breast+Cancer/26810192.html Fri, 24 Jul 2026 06:26:00 -0400 A.06822034 A.31066700 A.37819586 A.60012004 GILD O.00000304 O.00092067 O.01304637 O.20026344 O.22422661