Chimerix: Potential 'First' In Targeting Recurrent High-Grade Glioma Patients
Chimerix holds the potential to have the first approval of dordaviprone for treating recurrent H3 K27M mutant high-grade ...
Healio2d
FDA accepts IND for allogenic CAR T-cell therapy that could bypass lymphodepletion
The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...
Dallas Voice2d
FDA accepts Gilead’s new drug applications for lencapavir
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 ...
Medscape5d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
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.
Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia
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 ...
precisionmedicineonline1d
FDA Accepts Boehringer Ingelheim's New Drug Application for HER2-Targeted Therapy in NSCLC
In a Phase Ib trial, 71 percent of patients responded to zongertinib and lived a median six months before disease progression or death.
PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamineTORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- ...
dvm3606d
Laverdia-CA1's field trial ends, statistical analysis to begin
Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the ...
Targeted Oncology13d
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present February 10th at BIO CEO & Investor Conference
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 ...
manilatimes1d
Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil
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 ...