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Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

Friday the 13th proved lucky for Merck & Co., Inc.’s Keytruda (pembrolizumab), which claimed an approval bringing the immuno-oncologic into the triple negative breast cancer treatment space.

The US FDA’s other recent approvals highlight the evergreen value of improving convenience and tolerability for patients. Sebela Pharmaceuticals, Inc.’s Sutab offers an oral tablet alternative to unpleasant colonoscopy prep liquids

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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