Vinay Prasad will leave FDA CBER by end of April, returning to UCSF after a one-year sabbatical, following a prior departure ...

European Commission approval enables 2 mg/kg Q4W pegunigalsidase alfa for stable, ERT-treated adults, extending infusion intervals from Q2W to Q4W to lessen cumulative treatment burden. Evidence ...

Developments across the sector highlight a period of rapid acceleration and structural modernization. Welcome back to the PharmTech Weekly Roundup! I’m Susan Haigney, lead editor of PharmTech. There ...

AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.

FDA granted full approval to teclistamab plus daratumumab/hyaluronidase for RRMM after ≥1 prior line, marking first bispecific T-cell engager conversion from ...

FDA enforcement accelerated, with recent warning-letter volume exceeding the prior decade’s total, signaling a sustained departure from historical, reactive promotional oversight. “Sameness” ...

Norgine invests £23 million in Wales site to modernize production and boost resilience for UK and European medicine supply chains.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a ...

M capital investment will retrofit a 45‑acre Athlone site for high-volume oral GLP‑1 tableting, with phased completion in 2027–2028 to de-risk CMC supply. Designating Athlone as a primary ex-US ...

FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic ...