Summary: Investors and entrepreneurs will track decisions affecting drugs, medical devices and telehealth.
Summary: The agency’s openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
Summary: Companies need to reach the clinic quickly to prove they have a drug that can stand apart from competitors, according to executives and investors who spoke on a BioPharma Dive panel.
Summary: Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
Summary: Experts view BridgeBio’s acoramidis—which has an FDA action date of Nov. 29—as either similar to or incrementally better than Pfizer’s already established tafamidis.
