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, ...

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

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

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

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.

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 ...

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

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 ...

Based on data from the Beamion LUNG-1 trial, the FDA granted a priority review to zongertinib for patients with HER2-mutant ...

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