Sun Pharmaceutical Industries Limited. Sun Pharma announces US FDA acceptance of supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active ...

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

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

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

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 ...

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

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 ...

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” ...

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

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 ...