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

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

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 ...

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

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.

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food ...

Australian biotech Telix Pharmaceuticals (NASDAQ:TLX) announced late Tuesday that the U.S. Food and Drug Administration (FDA) has accepted its marketing application for TLX250-CDx and granted it ...

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

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 FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a ...

Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.