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

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 ...

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

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.

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

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.

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 under Priority Review the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, for the prevention of HIV as ...

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

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