US 6528305

GSK’s Blenrep returns to the US market after FDA approves resubmission

FDA · blood cancer · 5 min

The FDA has approved GSK’s Blenrep in combination with bortezomib and dexamethasone, clearing the drug’s return to the US market. The move ends a withdrawal that followed a failed confirmatory study and resets the catalyst timeline for investors and BD teams.

GSK Blenrep wins FDA approval in relapsed multiple myeloma

FDA · blood cancer · 6 min

GSK’s Blenrep has returned to the U.S. market after the FDA approved it in combination with bortezomib and dexamethasone for relapsed or refractory multiple myeloma. The catalyst matters for BD teams and investors because it reverses a prior withdrawal and resets the drug’s U.S. label and commercial outlook.

Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?

FDA · non-small cell lung cancer · 5 min

While many drugmakers are focused on lung cancer for PD-1/VEGF bispecifics, emerging evidence shows the liver may offer higher value. This analysis covers the mechanism, key players, and strategic implications for pharma teams.

This Week’s Biopharma News: New Approvals, Appeals, and AI

FDA · 10 min

This week's biopharma news highlights significant FDA approvals for Datroway and Hepcludex, a key appeal win for Outlook regarding bevacizumab, and promising Phase 3 data for BioMarin's VOXZOGO. The evolving landscape also sees increased integration of AI in drug development and regulatory processes.