USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.

Beyfortus cuts RSV hospitalizations across two seasons in landmark study

The NIRSE-GAL study, conducted in Galicia, Spain, is the first real-world, population-based investigation of a universal RSV immunization program spanning two consecutive seasons

Teva and Sanofi duvakitug Phase 2b data show sustained efficacy in IBD

Duvakitug was well tolerated and safety was consistent with the induction study

Roche appoints Mark Dawson as new Head of Pharma Research and Early Development

Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research

Dewpoint Therapeutics selects groundbreaking MYC development candidate

MYC, a master regulator of oncogenic transcription, drives multiple high-burden cancers but has long eluded direct pharmacologic control

Clinigen bags Japan's nod to human milk-based medicine for preterm infants

PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

STADA & Bio-Thera bag European nod for Gotenfia

Lundbeck’s bocunebart shows breakthrough potential in migraine prevention

Bocunebart works by blocking pituitary adenylate cyclase-activating polypeptide