Drug Approval | February 14, 2026
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
ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis
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
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
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
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
The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026
The goal of the agreement is to advance cell and gene therapy accessibility by enabling scalable and efficient cell therapy manufacturing
Myqorzo, a selective small-molecule cardiac myosin inhibitor, is designed to improve functional capacity and relieve symptoms in oHCM
BioNTech is positioning 2026 as a defining year in its transition toward a multi-product oncology company
Subscribe To Our Newsletter & Stay Updated
