Regulatory
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.
The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.
The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
The $7 billion transaction by Datavant with Ciox Health will be the nation’s largest “neutral and secure health data ecosystem.”
PRESS RELEASES