Zevra to net $150M from priority review voucher sale tied to Miplyffa approval
For Zevra Therapeutics, last year’s approval of the rare lysosomal storage disorder drug Miplyffa appears to be the gift that keeps on giving. | After receiving a rare pediatric disease priority review voucher in tandem with Miplyffa’s FDA green light in September,
The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for emapalumab-Izsg for use ...
Australian biotech Telix Pharmaceuticals (NASDAQ:TLX) announced late Tuesday that the U.S. Food and Drug Administration (FDA) ...
The US Food and Drug Administration has accepted for priority review the supplemental biologics license application for pembrolizumab (Keytruda) to treat patients with resectable, locally advanced ...
Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...
Zongertinib, an investigational treatment for HER2-mutant advanced NSCLC, has received FDA priority review, showing positive ...
Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...
Precigen on Tuesday said a green light would make PRGN-2012 the only FDA-approved therapeutic for the treatment of adults with the disorder, which is a lifelong neoplastic disease of the upper and ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback