BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

The acquisition, which will give Sanofi a combination vaccine for respiratory syncytial virus and human metapneumovirus, ...

The money will focus on a manufacturing plant in Virginia that will make the company's weight management and metabolic drugs ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

Avalyn Pharma has drawn in another fundraising round, this time a $100 million oversubscribed series D to continue developing ...

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

In this episode presented by Eclipsebio, BioSpace's head of insights Lori Ellis continues the discussion on mRNA and srRNA ...

In May, biotech iTeos Therapeutics decided to close down after being abandoned by GSK over the disappointing mid-stage performance of its anti-TIGIT antibody belrestotug.

What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according ...

The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly ...

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...