BriaCell spins off sCD80 cancer therapy to BriaPro in strategic deal

STADA & Bio-Thera bag European nod for Gotenfia

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.”

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

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

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA

The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies

Brenig Therapeutics launches first-in-human trial of novel neurodegenerative therapy

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026