KKR asks Fuji Soft to file injunction against Bain's 'breach of NDA'
U.S. private equity fund KKR said it has asked Fuji Soft to file for an injuction in court to stop what it said was Bain ...
Hosted on MSN3h
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive ...
USFDA accepts Sentynl's NDA for CUTX-101
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. Recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 ...
Cure Today3d
FDA Reviews NDA for Dordaviprone in Recurrent H3 K27M-Mutant Diffuse Glioma
Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...
Cure Today4d
FDA Accepts NDA for Avutometinib Plus Defactinib in KRAS+ Low-Grade Serous Ovarian Cancer
An NDA has been accepted by the FDA for the combination of avutometinib and defactinib in KRAS-mutated recurrent low-grade ...