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

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

Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...

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

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 ...

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.

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

The Food and Drug Administration (FDA) has accepted under Priority Review the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, for the prevention of HIV as ...

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application for zongertinib for the treatment of adult patients with ...

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.

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