Regulatory
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
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).
PRESS RELEASES