Regulatory
Abeona Therapeutics will head to the FDA next year for the potential approval of its experimental recessive dystrophic epidermolysis bullosa (RDEB) therapy following positive Phase III data.
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
CytoDyn withdrew its pending Biologics License Application for leronlimab in HIV, citing concerns involving the contract research organization managing its trials.
The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).
The FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving l-omburtamab for children with a rare form of neuroblastoma, citing complex review issues.
One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
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