Telix kidney cancer imaging agent granted FDA priority review
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 ...
Cure Today18h
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 ...
Targeted Oncology17h
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, ...
Pharm Exec20h
FDA Grants Priority Review to Merck’s Keytruda for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major ...
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 Today1d
Zongertinib Receives Priority Review For HER2 Mutant NSCLC
Zongertinib, an investigational treatment for HER2-mutant advanced NSCLC, has received FDA priority review, showing positive ...
Australian Associated Press11m
FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License ...
Bristol Myers Gets Speedy FDA Review of Opdivo/Yervoy Combo in Certain Colorectal Cancer Patients
Bristol Myers said about 5% to 7% of people with metastatic colorectal cancer have microsatellite instability-high or mismatch-repair-deficient tumors, adding that these patients are less likely to ...
2BMY : Bristol Myers Colorectal Cancer Treatment Goes Under Priority FDA Review
Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...
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 ...
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 ...
dermatologyadvisor1d
Dupilumab Gets Priority Review for Bullous Pemphigoid
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.