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

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

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

The FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a ...

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

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ataxia (SCA).

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for vatiquinone for the treatment of children and ...

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 ...

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 ...

The supplemental biologics license application for Dupixent for the treatment of bullous pemphigoid in adults has been accepted by the FDA for priority review, Sanofi announced in a press release.