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

Novartis won a bidding war against a fellow large drugmaker to acquire Regulus Therapeutics, according to a regulatory filing ...

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 ...

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

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

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 ...

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

The FDA approved Liquidia’s treprostinil program for two related kinds of high blood pressure, turning up the heat on rival ...

Sernova chairman Ross Haghighat resigns after DOJ indictment on 16 insider trading counts related to Novartis' $3.2B Chinook Therapeutics acquisition in 2023.