FDA leaders Makary, Prasad & Brenner will visit six US cities in June/July for discussions on regulatory modernization.

The FDA has rejected Savara’s application for its rare lung disease candidate over insufficient chemistry, manufacturing and ...

Boundless Bio halts BBI-355 monotherapy & combinations due to toxicity, shifts to BBI-355/BBI-825 combo. Cuts 33% of staff to ...

Gilgamesh's GM-2505 shows strong results in Phase 2a depression trial, with 21.6-point symptom reduction after two weeks vs ...

Plus, news about Lexeo, TreeFrog Therapeutics, Hansa Biopharma, AbbVie, Elpiscience Biopharmaceuticals, Immutep, Hedera Dx, ...

The CDC will no longer recommend routine Covid-19 vaccines for kids and pregnant women after HHS Secretary Robert F. Kennedy ...

Bio­gen is div­ing in­to the RNAi field with City Ther­a­peu­tics, a biotech led by sev­er­al for­mer Al­ny­lam lead­ers.

Rocket Pharmaceuticals said Tuesday morning that a patient in its gene therapy trial for Danon disease died after an 'acute ...

Prothena abandons birtamimab after Phase 3 amyloidosis trial failure, plans layoffs. Drug previously failed mid-stage trial.

ProteinQure raises $11M Series A led by Heron Rock to advance PQ203, a peptide-drug conjugate for triple-negative breast ...

Angelini will pay $50 million upfront and up to $520 million in biobucks to Grin for the ex-North America rights to ...

Indy biotech Syndeio launches with $90M, led by CEO Derek Small, to develop NMDA receptor drugs for depression & Alzheimer's, ...