Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...
Based on data from the Beamion LUNG-1 trial, the FDA granted a priority review to zongertinib for patients with HER2-mutant ...
The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) ...
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 vatiquinone for the treatment of children and ...
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).
Dupilumab, an interleukin-4 receptor antagonist, is expected to decrease the type 2 inflammation seen in bullous pemphigoid.
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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.
NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN), a biotechnology company with a market capitalization of $3.87 billion, announced today that the U.S. Food and Drug Administration (FDA) has accepted its ...
The application has been granted Priority Review and assigned a Prescription Drug User Fee Act, PDUFA, target action date of Aug. 19, 2025. “We are excited to be one step closer to bringing an ...