Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.
PDUFA
An FDA Panel Voted 9-3 Against Capricor on Cardiomyopathy and Never Voted on the Endpoint That Passed
The ballot was the outcome. A drug’s strongest dataset sitting off the voting question is not a footnote, it is the whole result.
LifeScience Weekly Digest: Key Industry Updates (6th – 10th January)
In early 2025, significant developments across the biopharmaceutical and medical device sectors shaped the healthcare landscape. Stryker’s $4.9 billion acquisition of Inari Medical, Transcarent’s $621 million deal for Accolade, and several FDA designations for investigational treatments, such as Johnson & Johnson’s nipocalimab, highlight industry advancements. Medicare’s rescinding of coverage for certain cancer genetic tests and … Read more
Regulatory Roundup: Weekly Insights on Pharma and MedTech—Key Updates from Leading Agencies (December 30th to January 3rd)
Welcome to this week’s Regulatory Insights from Synopulse, featuring the latest updates from the FDA, EMA, and other global regulatory authorities. From groundbreaking drug approvals to critical recalls and new designations, we cover the most significant events driving the pharmaceutical sector. This comprehensive report offers a concise view of the regulatory milestones shaping the pharma, … Read more