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 ...

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

Sernova chairman Ross Haghighat resigns after DOJ indictment on 16 insider trading counts related to Novartis' $3.2B Chinook ...

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

Hetero Labs could launch its generic sleep disorder drug as early as 2040 under a settlement deal with Axsome Therapeutics.

Eli Lilly is deepening its presence in the non-opioid pain field by buying California biotech SiteOne Therapeutics, which is ...

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

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

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

Trials for mental health drugs sometimes fail not because the medicine does not work, but because the measure of its effects is unreliable. Brooklyn Health’s technology aims to change that, and share ...

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