FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.
Latest
08:01 ET Soliton Announces FDA Clearance of Rapid Acoustic Pulse Technology for Use in Cellulite
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology,...
08:00 ET Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation
Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Defyne for the augmentation and correction of mild to...
Jan 29, 2021, 09:00 ET Medtronic Receives FDA Approval of DiamondTemp Ablation System for the Treatment of Patients with Atrial Fibrillation
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval...
Jan 28, 2021, 19:26 ET Ascentage Pharma Announces the Fifth Orphan Drug Designation Granted to Bcl-2 Inhibitor APG-2575 by the US FDA, and the Tenth Obtained by the Company
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic...
Jan 28, 2021, 11:10 ET icotec ag Announces the Market Launch of its BlackArmor® Anterior Cervical Plate in the United States
icotec ag, a leading medical device manufacture of BlackArmor® Carbon/PEEK implants, announces the United States market release of the world's first...
Jan 28, 2021, 09:30 ET Co-Diagnostics Completes FDA EUA Submission for Extraction-Free Saliva COVID-19 Test
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of...
Jan 28, 2021, 09:00 ET Immunoforge's 'PF1801' Is Designated as Orphan Drug by FDA
Immunoforge, the company specializing in the development of new drugs for rare musculoskeletal diseases (Representatives: An Seong-Min and Jang...
Jan 27, 2021, 19:00 ET Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and...
Jan 27, 2021, 07:30 ET Q BioMed's Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer
Q BioMed Inc. (OTCQB: QBIO), announced today that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan...
Jan 26, 2021, 19:26 ET Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA
Samsung Biologics (KRX: 207940.KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin...
Jan 26, 2021, 13:41 ET Inspired Spine announces Trident™ SI Joint Screw System Secures FDA 510(k) Approval
Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM), has secured FDA 510(k) marketing...
Jan 26, 2021, 09:00 ET RECORDATI RARE DISEASES: CARBAGLU® (Carglumic Acid) Tablets 200mg Receives U.S. FDA Approval for a New Indication to Treat Acute Hyperammonemia Associated with Propionic Acidemia and Methylmalonic Acidemia
Recordati Rare Diseases Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for CARBAGLU® (carglumic acid) ...
Jan 25, 2021, 17:45 ET Unmet Need in Lupus Nephritis Finally Addressed with New FDA Approvals for GlaxoSmithKline's BENLYSTA (belimumab) and Aurinia Pharmaceuticals' LUPKYNIS (voclosporin)
According to a survey of more than 200 US rheumatologists and nephrologists in mid-2020, the unmet need for new treatments for lupus nephritis (LN)...
Jan 25, 2021, 10:00 ET PEDRA™ Technology Receives FDA Breakthrough Device Designation for its PEDRA™ Xauron™ Real-Time Tissue Perfusion System
PEDRA™ Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough...
Jan 25, 2021, 08:30 ET FDA Approves Theranica's Nerivio® for Acute Treatment of Migraine in Adolescents
Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today...
Jan 25, 2021, 08:00 ET OrthoSpin Ltd. Receives FDA Regulatory Clearance for its G2 System
OrthoSpin Ltd. ("OrthoSpin"), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its ...
Jan 22, 2021, 21:12 ET Lupus Foundation of America Congratulates Aurinia Pharmaceuticals on FDA Approval of Lupkynis™ (voclosporin) to Treat Lupus Nephritis
For the second time in less than two months, the U.S. Food and Drug Administration (FDA) has approved a new medication to treat adults with lupus...
Jan 22, 2021, 07:00 ET Boston Scientific Receives FDA Approval For The Vercise Genus™ Deep Brain Stimulation System
Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep...
Jan 21, 2021, 16:21 ET FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the...
Jan 21, 2021, 13:16 ET Anivive Announces FDA Conditional Approval of LAVERDIATM-CA1 (verdinexor) - the First and Only Oral Tablet to Treat Lymphoma in Dogs
Anivive, a pharmaceutical startup using software to develop novel therapeutics for pets, is delighted to announce that its first commercial product,...
Jan 21, 2021, 08:30 ET FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Most of the news on advances for Covid-19 tend to focus on vaccines, however treatments are just as important. While vaccines can stop people from...
Jan 21, 2021, 07:30 ET Crescita Announces Filing of New Medical Device License
Laboratoires FILLMED files for Health Canada Approval of ART-FILLER® Injectables in Canada LAVAL, QC, Jan. 21, 2021 /PRNewswire/ - Crescita...
Jan 21, 2021, 07:00 ET Berkshire Biomedical Announces Acceptance of 510(k) Premarket Submission of Computerized Oral Prescription Administration™ (COPA) System
Berkshire Biomedical, LLC ("Berkshire" or "the Company"), a privately-held digital health company developing a revolutionary virtual care and...
Jan 20, 2021, 08:04 ET Le régulateur de débit auriculaire (AFR) d'Occlutech reçoit l'appellation de dispositif révolutionnaire pour l'insuffisance cardiaque (IC) de la part de la FDA
Occlutech, une société privée, a annoncé aujourd'hui que la Food and Drug Administration (FDA) des États-Unis a accordé à la société une désignation...
Jan 20, 2021, 08:00 ET Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance Of New Drug Application For INP104 For The Acute Treatment Of Migraine
Impel NeuroPharma, a late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review...
