FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Elig...
Merck & Company, Inc. (new) (MRK)
Last merck & company, inc. (new) earnings: 4/28 06:45 am
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Source: Business Wire
Applications are supported by the Phase 3 KEYNOTE-B15 results, which showed that KEYTRUDA plus Padcev demonstrated a statistically significant and clinically meaningful improvement in event-free survival and overall survival in study participantsIf approved, these regimens would be the first and only perioperative treatments for patients with MIBC regardless of cisplatin eligibility, marking potential new standards of care RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA
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News
- Merck Says FDA Grants Priority Review to Keytruda-Padcev Combo for Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- Does EU Approval Of ENFLONSIA Reshape The Bull Case For Merck's Pipeline Story (MRK)? [Yahoo! Finance]Yahoo! Finance
- Roche's DAC investment; Big Pharma's lavish CEO bumps [Yahoo! Finance]Yahoo! Finance
- Better Pharma Dividend Stock: Novartis vs. Merck [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
MRK
Earnings
- 2/3/26 - Beat
MRK
Sec Filings
- 4/8/26 - Form ARS
- 4/8/26 - Form DEFA14A
- 4/8/26 - Form DEF
- MRK's page on the SEC website