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 ...

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

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

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 ...

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

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

The drug is also approved in the U.S. and is under review in Canada, Brazil, South Korea and other countries. In a China phase 3 trial, the combo reduced the risk of death by 27% versus chemo ...

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 granted Priority Review to the New Drug Application for zongertinib for the treatment of adult patients with ...

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 ...

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 ...