Chimerix, a biopharmaceutical company, announced it has submitted a New Drug Application (NDA) to the FDA for accelerated approval of dordaviprone as a treatment for recurrent H3 K27M-mutant ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.

--Grace Therapeutics, Inc., a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 PR Newswire SHANGHAI and SAN DIEGO, May 22, 2025 ...

Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia FDA assigns a PDUFA target action date of October 23, 2025 ...

“KarXT is the first new class of treatment for patients with schizophrenia in several decades,” said Gang Wang, M.D., Dean of Beijing Anding Hospital, Capital Medical University and the ...

The FDA did not approve the initial new drug application for reproxalap in November 2023, as Healio previously reported.

A new drug application for Nubeqa, a potential treatment for patients with metastatic hormone-sensitive prostate cancer, was accepted by the FDA. The Food and Drug Administration (FDA) accepted a ...

The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer.

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.