The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.
FDA Action Alert: PTC and Roche, Lipocine, Incyte and Morphosys, and BMSAdults, Babies, Children, Clinical Trials, Complete Response Letter, FDA, FDA/Regulatory, NDA Resubmission, New Drug Applications, PDUFA, Priority Review, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Spinal Muscular Atrophy (SMA), Survival motor neuron 1 (SMN1) gene, Survival Motor Neuron 2 (SMN2) Gene
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
Clinical-stage biopharmaceutical company Zosano Pharma Corporation announced a partnership with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta in the United States.
Results of a pivotal phase III study of Supernus Pharmaceuticals’ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics.
The U.S. Food and Drug Administration accepted the filing of Aurinia Pharmaceuticals Inc.’s New Drug Application (NDA) for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
FDA Action Alert: Jazz, ANI and UltragenyxApprovals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative Colitis
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for Mallinckrodt’s investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
A look at the U.S. Food and Drug Administration’s drug approval review calendar.
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and SunovionBlockbusters, BRCA mutation, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, Parkinson's Disease, PDUFA, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.