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

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 ...

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.

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

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

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

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

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