The U.S. Food and Drug Administration sent a letter to Ardelyx Inc. citing “deficiencies” found in the company’s evaluation of the biopharmaceutical firm’s new drug to treat chronic kidney disease (CKD).
Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.
FDA Action Alert: Merck, Aurinia and AmgenAmgen, Business, Calcineurin Inhibitors (CNI), Chronic Heart Failure, Clinical Trials, Collaborations, Deals, FDA, FDA, Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS), Lupus nephritis, Merck, Myelosuppression, New Drug Application (NDA), PDUFA, Priority Review, R&D, Systemic Lupus Erythematosus (SLE)
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.
Fast Track, Breakthrough and Priority Reviews: Sanofi and ViiVAcid alpha-glucosidase (GAA) enzyme, Biologics License Application (BLA), Breakthrough Therapy Designation, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Immune Thrombocytopenia (ITP), Clinical Trials, Enzyme Replacement Therapy (ERT), Fast Track Designation, FDA, HIV pre-exposure prophylaxis (PrEP), HIV Prevention, Muscle Disease, Orphan Drug Designation, PDUFA, Pompe disease, Priority Review Status, R&D, Sanofi
The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
Correvio Pharma Corp. announced that the U.S. Food and Drug Administration accepted for review the resubmitted New Drug Application (NDA) for the antiarrhythmic drug Brinavess.
Bausch + Lomb announced the U.S. FDA accepted the New Drug Application for the company’s sub-micron loteprednol etabonate ophthalmic gel 0.38% with a PDUFA date of Feb. 25, 2019.
Nine Biotechs Facing FDA Decisions in December 2017Active Psoriatic Arthritis (PsA), Biopharma, Biosimilars, Biotech, Breast Cancer, Chronic Myeloid Leukemia (CML), Contraceptives, FDA, FDA/Regulatory, Glucagon-Like Peptide-1 (GLP-1) Analogs, Growth Hormone Deficiency (GHD), Hormonal Contraceptive Patches, New Drug Application (NDA), New Drug Applications, OTC, Patches, PDUFA, Supplemental Biologics License Application (sBLA), Supplemental New Drug Application (sNDA), Supplemental New Drug Application (sNDA), Type 2 Diabetes
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.
FDA’s commissioner told staff in an email that he intends to delay any labor reductions until the end of September unless Congress authorizes its user fee program to provide the necessary funding.