Zevra has sold its US Food and Drug Administration (FDA) priority review voucher (PRV) for $150m to an undisclosed party.

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.

For Zevra Therapeutics, last year’s approval of the rare lysosomal storage disorder drug Miplyffa appears to be the gift that ...

Zongertinib, an investigational treatment for HER2-mutant advanced NSCLC, has received FDA priority review, showing positive ...

Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major ...

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 ...

The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...

Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...

The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...

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.

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 ...

Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...