Pharm Exec2h
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 ...
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 ...
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 ...
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 – ...
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.
GlobalData on MSN5d
FDA grants priority review for Boehringer’s zongertinib NDA in NSCLC
The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) ...
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 ...
Targeted Oncology6d
FDA Grants Priority Review to Zongertinib in HER2-Mutant NSCLC
Based on data from the Beamion LUNG-1 trial, the FDA granted a priority review to zongertinib for patients with HER2-mutant ...
Medscape5d
Dupilumab Under FDA Priority Review for Bullous Pemphigoid
Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.
Targeted Oncology6d
FDA Gives Dordaviprone Priority Review in H3K27M-Mutant Diffuse Glioma
The FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a ...
Merck Gets Speedy FDA Review of Keytruda in Certain Head, Neck Cancers
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its blockbuster cancer drug Keytruda in certain patients with head and neck cancer.
Monthly Prescribing Reference4d
Zongertinib Under Review for HER2-Mutant Advanced NSCLC
The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application for zongertinib for the treatment of adult patients with ...