ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis
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.”
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
The therapy is currently completing Phase 1 clinical trials in renal cell carcinoma and non-small cell lung cancer
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
These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers
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