FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers.

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

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 endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

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

The industry is shifting toward increasingly complex, precision-driven modalities for the treatment of cancer.

FDA vaccine chief Dr. Vinay Prasad is leaving for the second time in a year amid controversies that disrupted multiple drug and vaccine development programs.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

Developments across the sector highlight a period of rapid acceleration and structural modernization.

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

The author discusses analytical techniques for cleaning and disinfection, clean room operation, packaging component preparation, water-for-injection production, sterile product preparation, and aseptic filling, stoppering, and sealing.

The FDA's new era of proactive enforcement uses warnings to stop misleading GLP-1 ads and ensure a fair balance of drug risks and benefits.

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

Sartorius' new engineered host cell line triples productivity and doubles expression titers while maintaining long-term genetic stability.

FDA granted Hernexeos accelerated approval for 1st-line HER2-mutant NSCLC after a 44-day review via the National Priority Voucher Program.

Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for global markets by 2028.

EMA's Feb 2026 meeting resulted in the recommendation of 12 medicines, including a combined flu/COVID vaccine among the six biosimilars and six therapeutic extensions.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

Ken Boda, Agilent, discusses small-volume dissolution for low-dose drugs and implants, emphasizing biorelevance, USP apparatuses, and technical risks.

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty pharmaceutical platform.

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic benefits for 82 million patients.

Univar Solutions' Ingredients + Specialties division has been appointed as the distributor for Ingredion Pharma Solutions, creating an exclusive distribution channel for pharmaceutical starches within the United States and Canada.

Elisabeth Gardiner, PhD, CSO of Tevard Biosciences, explains some of the challenges associated with the development of treatments for rare diseases.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before uncertainty becomes late-stage risk.