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

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.

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

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

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

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 accepted for Priority Review the New Drug Application (NDA) for vatiquinone for the treatment of children and ...

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 ...

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of ...

Based on FDA Priority Review timelines and if ultimately approved, Biohaven is prepared to commercialize troriluzole for SCA in the US in 2025. Melissa Beiner, M.D., SCA Clinical Development Lead ...

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