The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...

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

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 ...

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.

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 ...

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

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

The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) ...

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

Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...

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