Ono Pharmaceutical’s vimseltinib to treat tenosynovial giant cell tumour gets US FDA approval: Osaka Friday, February 21, 2025, 15:00 Hrs [IST] Ono Pharmaceutical, one of the la ...

The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a ...

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

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech ...

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

BridgeBio’s ATTR cardiomyopathy drug, Attruby, achieved promising sales numbers in the weeks after its FDA approval.

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

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 ...

The Food and Drug Administration (FDA) has approved Romvimza ™ (vimseltinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will ...

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 ...