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 ...

On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA ...

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

A licensing structure assigns SteinCares end-to-end Latin America market execution while Shilpa retains development and sustained commercial supply responsibilities. The collaboration targets wider ...

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%.

FDA approves leucovorin for cerebral folate deficiency, signaling how literature-based evidence can support rare disease approvals without clinical trials.

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 ...

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a ...

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 ...

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

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 ...