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) ...

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

Priority Review Vouchers (PRVs) are transferable and, in past transactions by other companies, have sold for prices up to $350 million ...

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

Dupilumab, an interleukin-4 receptor antagonist, is expected to decrease the type 2 inflammation seen in bullous pemphigoid.

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).

Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir the ...

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Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 ...