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 ...

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

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

US early-phase trial velocity is constrained by hospital contracting, IRB workflows, and IND review timelines, elevating the ...

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 ...

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

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

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before ...

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