The FDA Said No. Europe Said Yes. Someone Is Wrong About Camizestrant.
AstraZeneca's Etcamah won EMA approval weeks after FDA adcom rejection—exposing a regulatory split that demands answers on endpoint standards...
Aardvark’s Clinical Hold Isn’t Bad Luck — It’s a Pre-Clinical Characterization Failure
FDA placed a full clinical hold on Aardvark's ARD-101 after a cardiac event in a healthy volunteer. Here's what...
BeOne Medicines Got Caught Running a Blood Cancer Ad That Outran Its Own Data
FDA flagged BeOne's Brukinsa TV ad 'Clarity' for misleading visuals—BeOne's third OPDP enforcement letter in under 18 months. Here's...
The FY2024 BIMO Report Confirms It: Sponsor Oversight Failures Are Now Structural
FDA's FY2024 Bioresearch Monitoring report shows 25% of sponsor inspections drew a Form 483, with the same recurring findings...