STADA & Bio-Thera bag European nod for Gotenfia

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

Lundbeck’s bocunebart shows breakthrough potential in migraine prevention

Bocunebart works by blocking pituitary adenylate cyclase-activating polypeptide

Centivax launches first human trial of universal flu vaccine

FDA nod to Acrotech's new eczema treatment

ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients

Roche BTK drug emerges as potential breakthrough in primary progressive MS

Biomica seals exclusive global license for groundbreaking microbiome cancer therapy

The therapy is currently completing Phase 1 clinical trials in renal cell carcinoma and non-small cell lung cancer

MHRA warns of extremely rare vision risk linked to semaglutide

Semaglutide—a glucagon?like peptide?1 receptor agonist (GLP-1RA) sold as Ozempic and Rybelsus for type 2 diabetes, and Wegovy for weight management and cardiovascular risk reduction