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 ...

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

Welcome back to the PharmTech Weekly Roundup! I’m Susan Haigney, lead editor of PharmTech. There were some strategic investments made by industry this week, and FDA called out misleading claims about ...

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

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

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

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

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 ...

Harry G. Brittain, PhD, is the director of the Center for Pharmaceutical Physics and a member of Pharmaceutical Technology 's editorial advisory board. 10 Charles Rd., Milford, NJ 08848, tel.