Pharma & Biotech - Page 3

Daiichi Sankyo subsidiary American Regent is recalling three lots of generic epinephrine injection vials distributed across the United States amid concerns over particulate contamination and packaging failures. The recall follows customer complaints

Ionis Pharmaceuticals has secured FDA approval for Zanvastro, marking a landmark moment as the first disease-modifying therapy ever cleared for Alexander disease. The approval arrived more than two weeks ahead of its

The Trump administration has announced nine new Most-Favored-Nation agreements with pharmaceutical manufacturers, significantly broadening the reach of the pricing programme. The latest additions bring the total number of companies participating in the

Over 600,000 seniors have enrolled in the Medicare GLP-1 Bridge program within just two months of its July 2026 launch, according to the White House. The program, which emerged from the Trump

Akeso and Summit Therapeutics’ (SMMT) ivonescimab has cleared another clinical milestone, meeting its overall survival endpoint in the trial that first put the drug on the map. The PD-1xVEGF bispecific antibody generated

CMI Media Group, a precision healthcare communications company and subsidiary of WPP (NYSE: WPP), has formally launched a new specialty communications business unit. The Philadelphia-based organisation has long focused on developing proprietary

Fresenius, the German drugmaker, has received a warning letter from the US Food and Drug Administration targeting its Fenwal blood-products facility in Puerto Rico. The FDA issued the warning following an inspection

Replimune (REPL) secured a landmark accelerated approval for its cancer therapy Tudriqev last month, following a pivotal intervention from senior FDA leadership. Two votes of confidence from officials at the FDA’s Office

Amgen (AMGN) has unveiled compelling new data showing its cholesterol-lowering drug Repatha significantly reduces the risk of death in high-risk cardiovascular patients. The findings, announced on 31 August 2026, come from a

The pharmaceutical distribution industry is closely watching the development of a national licensure standard that could reshape compliance requirements for wholesalers and third-party logistics providers. Kala Shankle, JD, Vice President of Regulatory