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

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

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 ...

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

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

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 ...

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 ...

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, ...

Building on the buzz around a celebrated early trial readout, GSK’s Jemperli has earned a first-in-class FDA approval in a ...

Following a bumpy regulatory road that involved a refusal-to-file, ImmunityBio has won FDA approval to expand Anktiva into ...