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 ...

Teclistamab plus daratumumab gains FDA approval for relapsed/refractory multiple myeloma, showing 83% reduction in disease progression versus standard care.

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.

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 ...

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

Click here to view the Pharmaceutical Technology Europe TM September/October 2025 issue.

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.