regulatory

News

The FDA has raised the pressure on Amgen to withdraw vasculitis drug Tavneos from the market with a report linking serious side effects to the drug.

R&D

Exploring a systemic challenge in translating biological promise into reliable human efficacy and safety.

News

Shares in Anavex Life Sciences lost more than a third of their value today after the company abandoned an EU filing for its Alzheimer's therapy.

News

The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by executive chair, billionaire Patrick Soon-Shiong.

News

FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.

News

New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.