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

Oct 13, 2020, 20:03 ET Direct Biologics Granted Expanded Access by FDA for ExoFlo™ in the Treatment of COVID-19

Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated...


Oct 13, 2020, 09:06 ET ImmersiveTouch Announces FDA Clearance and U.S. Launch of IVSP®, the First Virtual-Reality Surgical Planning Service for Oral & Maxillofacial Surgery

ImmersiveTouch Inc., a global leader in next-generation medical technology, is pleased to announce that the Food and Drug Administration (FDA) has...


Oct 13, 2020, 09:00 ET Now Over-the-Counter: FDA Clears CEFALY® DUAL Migraine Treatment for Use Without a Prescription

CEFALY Technology today announced that the U.S. Food and Drug Administration (FDA) has cleared the CEFALY DUAL medical device as an over-the-counter...


Oct 12, 2020, 12:44 ET First Clinical Cases in the USA to treat vertebral fracture with Spinal Implant Product V-STRUT© developed by HYPREVENTION

Hyprevention team is pleased to announce the first clinical cases performed in the USA with the V-STRUT© Vertebral Implant product to treat vertebral ...


Oct 12, 2020, 09:00 ET Abbott Receives FDA Emergency Use Authorization for its COVID-19 IgM Antibody Blood Test

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's...


Oct 12, 2020, 07:30 ET CartiHeal Receives FDA "Breakthrough Device Designation" for the novel Agili-C Implant

CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today ...


Oct 12, 2020, 07:00 ET Oxular Receives Rare Paediatric Disease and Orphan-Drug Designations for Retinoblastoma Treatment

Oxular Limited ("Oxular"), a leading retinal therapeutics development company, today announces it has received both Rare Paediatric Disease and...


Oct 12, 2020, 04:45 ET FDA grants Glycostem's oNKord® Orphan Drug Designation for Multiple Myeloma

Glycostem Therapeutics, a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, announces ...


Oct 11, 2020, 20:30 ET Gannex Received U.S. IND Approval for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672) announces today that it received investigational new drug...


Oct 09, 2020, 17:11 ET FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

Alkermes plc (Nasdaq: ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and...


Oct 09, 2020, 08:00 ET Beckman Coulter SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization

Beckman Coulter, a clinical diagnostics leader, today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use...


Oct 09, 2020, 07:05 ET Trading in Alkermes Ordinary Shares Halted Today

Alkermes plc (Nasdaq: ALKS) today announced that Nasdaq has temporarily halted trading of the company's ordinary shares. The joint meeting of the...


Oct 08, 2020, 20:10 ET Ascentage Pharma's Apoptosis-Targeting Drug Candidates Granted Two More Orphan Drug Designations by the US FDA

Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic...


Oct 07, 2020, 15:00 ET ZEUS Scientific Announces FDA EUA Approval for ZEUS ELISA™ SARS-CoV-2 IgG Test System

ZEUS Scientific announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its in...


Oct 07, 2020, 09:17 ET Le premier médicament commercial fabriqué au moyen de la technologie AJIPHASE d'Ajinomoto Bio-Pharma Services reçoit l'approbation de la FDA

Ajinomoto Bio-Pharma Services (« Aji Bio-Pharma »), un fournisseur de premier plan de services de développement et de fabrication biopharmaceutique...


Oct 07, 2020, 09:15 ET Erstes kommerzielles Medikament, das über die AJIPHASE-Technologie von Ajinomoto Bio-Pharma Services hergestellt wird, erhält FDA-Zulassung

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), ein führender Anbieter von biopharmazeutischen Auftragsentwicklungs- und...


Oct 07, 2020, 08:31 ET BioMarin, Pioneer in Rare Disease Treatments for Phenylketonuria (PKU), Receives FDA Approval of Label Expansion to Allow Maximum Dose of 60 mg for Palynziq® (pegvaliase-pqpz) Injection for Treatment of Adults with PKU

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics...


Oct 07, 2020, 08:26 ET MNGO Receives Important Filing Letter from FDA in Premarket Tobacco Product Application (PMTA) Process

MNGO, maker of e-Cigarettes and disposable vaping products, announced today that it has advanced to the "Filing" stage of the FDA's Premarket Tobacco ...


Oct 06, 2020, 12:27 ET El primer fármaco comercial fabricado a través de la tecnología AJIPHASE de Ajinomoto Bio-Pharma Services recibe la aprobación de la FDA

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), un proveedor líder de servicios de desarrollo y fabricación contractual de biofarmacéuticos, se...


Oct 06, 2020, 09:56 ET First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services' AJIPHASE Technology Receives FDA Approval

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased ...


Oct 06, 2020, 09:15 ET Biosense Webster Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation

Johnson & Johnson Medical Devices Companies** today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster,...


Oct 05, 2020, 06:52 ET BD Granted FDA 510(k) Clearance for BD FACSLyric™ Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance from...


Oct 04, 2020, 18:50 ET TaiGen filed US IND for its influenza antiviral TG-1000

TaiGen Biotechnology Company, Limited ("TaiGen") announced today that it has filed an Investigational New Drug (IND) application with the US FDA for...


Oct 02, 2020, 20:36 ET Haemonetics Receives FDA Clearance For NexSys PCS® With Persona™ Technology

Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better...


Oct 02, 2020, 16:02 ET FDA Approves Drug Combination for Treating Mesothelioma

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of...