Regulatory
Concerns over vaccination links to heart inflammation are valid, a U.S. Centers for Disease Control and Prevention advisory committee announced this afternoon.
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
The medical regulator’s green light is a milestone in the global fight against specific types of late-stage blood cancer, as CAR T-cell therapy has been found to be effective against them.
Please check out the biopharma industry’s COVID-19 stories that are trending for June 22, 2021.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
The FDA granted it to Lu-PSMA-617, an investigational radioligand therapy to treat metastatic castration-resistant prostate cancer.
Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond its newly-approved aducanumab has hit a clinical snag after gosuranemab failed.
The U.S. FDA approved Ayvakit for the treatment of adult patients with advanced sytematic mastocytosis (SM), advanced SM, and mast cell leukemia.
Both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI.
Please check out the biopharma industry’s COVID-19 stories that are trending for June 15, 2021.
PRESS RELEASES