Chimerix holds the potential to have the first approval of dordaviprone for treating recurrent H3 K27M mutant high-grade ...

The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the company’s  “new drug applications” for lencapavir, a twice-yearly ...

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of ...

The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

In a Phase Ib trial, 71 percent of patients responded to zongertinib and lived a median six months before disease progression or death.

The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the ...

Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...

Milestone's NDA for CARDAMYST is currently under review at the FDA with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. The Company continues to advance commercial preparations ...