If approved, Dupixent would be the first biologic medicine available in the U.S. for these children
This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.
Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.
Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.
Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”
Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.
Cognita Labs, a respiratory technologies company, announced U.S. Food and Drug Administration (FDA) clearance for CapMedic, world's first interactive digital inhaler sensor for asthma, Chronic Obstructive Pulmonary Disease (COPD) and other pulmonary conditions.
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Critical Milestone Reached in Response to this Outbreak
KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients
RRP is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting
Ethos represents a new chapter in democratized cancer care
Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company's product has been granted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program for the treatment of "multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed."
FDA Grants Priority Review and sets PDUFA Date of August 13, 2020
FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs
MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.
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The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts.
Expand TAZVERIK™ Label into Second Indication
First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail