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 ...

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 ...

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

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.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative ...

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 ...

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

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

M capital investment will retrofit a 45‑acre Athlone site for high-volume oral GLP‑1 tableting, with phased completion in 2027–2028 to de-risk CMC supply. Designating Athlone as a primary ex-US ...