In its own approval announcement on Oct. 20, the FDA hailed Hibsago as a “first-of-its-kind” treatment in chronic hepatitis B ...

The FDA is codifying its regulations around mobile apps that go along with prescription drugs, offering a clearer framework ...

Next-gen manufacturer Antheia is teaming up with the U.S. Department of War to build out its infrastructure and onshore the U.S. drug supply chain.  | The Department of War is allotting a conditional ...

With the win fleshed out, AZ and Amgen are now eyeing regulatory filings to carve out a potential third indication for ...

AbbVie has formed a multiyear deal with the McLaren Formula 1 team, signing up to raise awareness of immune-mediated diseases ...

Veradermics is keeping pace in an already high-octane year.  | Topline results show the biotech's lead asset, VDPHL01, ...

Cosette Pharmaceuticals has achieved a corporate milestone, securing an FDA approval for a legacy Daiichi Sankyo drug in its ...

Ahead of a planned strike by the CDMO’s labor union later this month, Samsung Biologics has secured a Korean court ruling in its favor, shielding the bulk of its drug substance manufacturing from ...

Eli Lilly is betting on a pediatric expansion to give it’s IL-23p19 inhibitor Omvoh an edge in the fiercely competitive ...

Amid a steady advance of kidney-focused label expansions, Novartis’ Fabhalta is slowing its roll in a key potential autoimmune niche.  | Amid a steady advance of kidney-focused label expansions, ...

Amid tensions over government healthcare cost-cutting policies, Roche has slammed the brakes on new investments in Germany, joining an expanding group of drugmakers pulling back from the European ...

In the fiercely competitive inflammatory bowel disease (IBD) market, Eli Lilly is making the case for its antibody Omvoh as a ...