IRA revisions now exempt multi-indication orphan drugs from price negotiations, improving lifecycle economics and encouraging ...

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

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. This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic ...

For INTERPHEX NYC, taking place April 21-23, groninger will debut a formalized service structure and put a high-throughput ready-to-use processing platform in front of industry decision-makers.¹ Its ...

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers. On March 11, the FDA launched a unified ...

The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.

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 ...

Japan's largest pharma event returns May 2026 with 320 sessions spanning manufacturing, quality, CMC, and digital transformation.

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

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” ...