FDA Accepts Blueprint Medicine’s AYVAKIT® Supplemental NDAs for Treatment of Indolent Systemic Mastocytosis
Blueprint Medicines announces FDA acceptance of AYVAKIT® supplemental NDA for indolent systemic mastocytosis treatment. FDA grants priority review with May 22, 2023 action date under PDUFA. Results fr ...
FDA approves treatment for schizophrenia in pediatric patients
Otsuka and Lundbeck's supplemental new drug application (sNDA) for brexpiprazole to treat schizophrenia in pediatric patients aged 13 to 17 years has been approved by the US Food and Drug Administrati ...
Verismo Therapeutics Receives Fast Track Designation from FDA for SynKIR-110, a Novel CAR T Therapy for Mesothelioma Treatment
Verismo Therapeutics, a clinical-stage company specializing in CAR T technology, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug, SynKIR-11 ...
Pharming Group’s Joenja® receives FDA approval for the treatment of rare APDS condition in Adults and Pediatric patients
Pharming Group N.V. has received FDA approval for Joenja® (leniolisib) to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in patients aged 12 and above. Joenja® is a selective ...
FDA Grants Priority Review for OPNT003 Nasal Nalmefene to Treat Opioid Overdose
The FDA has accepted for Priority Review the New Drug Application for Opiant Pharmaceutical's OPNT003, an intranasal formulation containing the high-affinity opioid antagonist nalmefene, for the treat ...