The latest drug development news and highlights from our US FDA Performance Tracker.
The calendar officially turned to summer in the northern hemisphere, and the US Food and Drug Administration came in already sizzling hot with action. Here's your news in brief:
The biggest news of the week was the FDA's approval of AMAG Pharmaceuticals Inc.'s Vyleesi (bremelanotide), which became the...
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
