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Zevra sells priority review voucher for $150m to support drug launches
Zevra has sold its US Food and Drug Administration (FDA) priority review voucher (PRV) for $150m to an undisclosed party. The ...
Targeted Oncology3h
FDA Grants Priority Review to TLX250-CDx in Kidney Cancer
The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...
Zevra Therapeutics to Sell Priority-Review Voucher for $150 Million
Zevra Therapeutics has inked a deal to sell its Food and Drug Administration priority-review voucher to an undisclosed buyer for gross proceeds of $150 million.
FiercePharma1d
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 ...
Targeted Oncology3d
FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC
The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...
Cancer Therapy Advisor1d
Pembrolizumab Granted Priority Review for Resectable, Locally Advanced HNSCC
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 ...
Cure Today3d
FDA Accepts Priority Review for Pre- and Postsurgical Keytruda in HNSCC
The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...
Merck’s application for keytruda in HNSCC granted priority review by FDA
Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...
Cure Today4d
Zongertinib Receives Priority Review For HER2 Mutant NSCLC
Zongertinib, an investigational treatment for HER2-mutant advanced NSCLC, has received FDA priority review, showing positive ...
Zevra Therapeutics Enters Agreement to Sell its Rare Pediatric Disease Priority Review Voucher for $150 Million
Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced that it has entered ...
Gilead’s lenacapavir under priority review could revolutionise HIV PrEP
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...
Precigen Gets FDA Priority Review of Recurrent Respiratory Papillomatosis Treatment
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 ...