Following formal sign-off from the FDA, Handa Pharmaceuticals’ branded drug reformulation strategy has paid off for a third ...

In his first interview after taking the reins of the FDA’s Oncology Center of Excellence (OCE), Angelo de Claro, M.D., is ...

Takeda's long-time R&D chief Andy Plump will retire. Daiichi Sankyo beat back a $1.3 billion damage claim in a lawsuit.

With positive phase 3 results in hand, AbbVie is one step closer to expanding the reach of its key migraine preventative ...

Argonaut Manufacturing Services, a CDMO specializing in aseptic fill-finish for injectable biologics and other drugs, has ...

In a series of moves by Switzerland-headquartered CDMOs this week, manufacturing powerhouse Lonza is doubling down on its US ...

Bayer has won first-line approval for its tyrosine kinase inhibitor, Hyrnuo, in patients with HER2-mutant non-small cell lung ...

Caris Life Sciences is signing up Hollywood legend Kevin Costner to break down the importance of early cancer detection—and ...

In a rare divergence from its own expert panel, the FDA has granted accelerated approval to AstraZeneca’s camizestrant, ...

Following a monthslong interregnum at the U.S. Food and Drug Administration, the leadership pieces are again locking into ...

In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival ...

Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer ...