Fda
FDA accepts resubmission of sBLA for Dupixent for chronic spontaneous urticaria
The FDA has accepted the resubmission of the supplemental biologics license application for Dupixent to treat chronic spontaneous urticaria in adults and children, Regeneron Pharmaceutical and Sanofi announced in a press release.
Corin receives FDA 510(k) clearance of Icona femoral stem
Corin has received FDA 510(k) clearance of its Icona femoral stem for direct anterior total hip arthroplasty with design considerations for use in the ASC setting, according to a press release.
FDA approves novel gene therapy for rare neurometabolic disorder
The FDA has approved an adeno-associated virus vector-based gene therapy to treat both adult and pediatric patients with aromatic L-amino acid decarboxylase deficiency.
FDA grants breakthrough therapy designation to nipocalimab for Sjögren’s disease
The FDA has granted breakthrough therapy designation to nipocalimab, a novel neonatal Fc receptor blocker, for the treatment of moderate to severe Sjögren’s disease, according to a press release from Johnson & Johnson.
FDA accepts new drug application for donidalorsen
The FDA accepted a new drug application for review of donidalorsen, a prophylactic RNA-targeting drug used to prevent hereditary angioedema attacks in patients aged 12 years and older, according to a press release from Ionis.
FDA approves obecabtagene autoleucel for adult leukemia treatment
The FDA has approved obecabtagene autoleucel for the treatment of adults with relapsed refractory B-cell precursor acute lymphoblastic leukemia.
FDA extends Prescription Drug User Fee Act date for macular telangiectasia type 2 therapy
The FDA has extended its Prescription Drug User Fee Act date for the biologics license application for NT-501, a treatment for macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.
FDA extends target action date for Vtama cream sNDA for atopic dermatitis
The FDA has extended the target action date of its review of the supplemental new drug application for Vtama cream 1% for the treatment of atopic dermatitis in adults and children aged at least 2 years, Organon announced in a press release.
FDA proposes removing oral phenylephrine from nasal decongestants
The FDA has proposed an order for the removal of oral phenylephrine as an active ingredient from over-the-counter monograph drug products for relieving nasal congestion, according to an administration press release.
GPT-4 responses to anti-obesity medication questions comparable to FDA answers
SAN ANTONIO — When asked common questions regarding anti-obesity medications, GPT-4 responses were easy to interpret, accurate and comparable to responses provided by the FDA, according to findings presented at ObesityWeek.