This week, Peter Simons covers a
BMJ investigation that found the FDA's "accelerated approval" process has left ineffective drugs on the market, some for more than 20 years, without follow-up studies to demonstrate efficacy. He also covers further developments in the FDA and Biogen controversy around Alzheimer's drug aducanumab (Aduhelm).
- FDA's "Accelerated Approval" Process Leaves Ineffective Drugs on the Market
- Do we all have Alzheimer's? Drug makers might want you to think so
- Biogen pulled Aduhelm paper after JAMA demanded edits
- Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee
- Sage Therapeutics axes 2 zuranolone trials deemed unnecessary for approval in depression