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

08:00 ETMEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System

MEDICALgorithmics, S.A. (WSE: MDG) and U.S. subsidiary Medi-Lynx Cardiac Monitoring L.L.C., today announced that the U.S. Food and Drug...


08:00 ETAllergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track...


07:30 ETAmneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received U.S. Food and Drug Administration...


06:33 ETIDT's Customer Senseonics Receives FDA Approval for its Implantable Glucose Sensor

Integrated Device Technology, Inc. (IDT) (NASDAQ: IDTI), announced that its customer Senseonics (Germantown, MD) received FDA approval for its...


Jul 20, 2018, 11:43 ETFDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory...


Jul 19, 2018, 09:15 ETBioPharmX Announces FDA Grant of CARC Waiver and Post-Hoc Analysis for BPX-01

BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced that...


Jul 18, 2018, 12:59 ETNovartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women

Novartis today announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor...


Jul 18, 2018, 11:17 ETFDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of...


Jul 18, 2018, 08:00 ETPainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study

PainReform Ltd, developer of a proprietary reformulation technology, has received FDA approval to conduct two pivotal Phase III clinical trials for...


Jul 18, 2018, 04:00 ETAsceneuron's Tau Modifier ASN120290 Receives Orphan Drug Designation for Progressive Supranuclear Palsy From the FDA

Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles Asceneuron SA, an emerging leader in the development of...


Jul 18, 2018, 04:00 ETAsceneuron's Tau Modifier ASN120290 Receives Orphan Drug Designation for Progressive Supranuclear Palsy From the FDA

Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles Asceneuron SA, an emerging leader in the development of...


Jul 17, 2018, 17:31 ETJanssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the...


Jul 17, 2018, 15:40 ETZavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage)

Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today that ...


Jul 17, 2018, 10:44 ETGuarulhos vai fornecer novos glicosímetros para diabéticos

A Secretaria Municipal da Saúde (SMS) de Guarulhos (SP), em parceria com a IQUEGO e HMD Brasil, acaba de disponibilizar gratuitamente 16 mil novos...


Jul 17, 2018, 09:01 ETCandela Announces FDA Clearance Of Vbeam® Prima

Candela Corporation, a leading global aesthetic device company, announces the U.S. Food and Drug Administration (FDA) clearance of its Vbeam® Prima,...


Jul 16, 2018, 08:30 ETCalcitriol New Contract Manufacturing Submission Receives FDA Approval and Allows Rockwell Medical Commercialization of Calcitriol

Rockwell Medical, Inc. (NASDAQ: RMTI) (the "Company") today provided an update regarding Calcitriol, the Company's FDA approved active vitamin D...


Jul 16, 2018, 08:00 ETStryker receives US FDA Pre-market approval for the Surpass Streamline™ Flow Diverter to treat large and giant unruptured aneurysms

Stryker Corporation announced today that the U.S. Food and Drug Administration has granted pre-market approval (PMA) for the Surpass Streamline Flow...


Jul 16, 2018, 07:00 ETMaxCyte Receives US FDA Investigational New Drug Clearance for First Clinical Program

MaxCyte announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to begin a clinical...


Jul 16, 2018, 02:29 ETCamurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder

Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date ...


Jul 13, 2018, 15:00 ETFDA approves the first drug with an indication for treatment of smallpox

The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the...


Jul 13, 2018, 14:30 ETU.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and...


Jul 13, 2018, 14:18 ETRoche PCT assay cleared for expanded use - Important tool in antibiotic resistance crisis

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the expanded...


Jul 13, 2018, 01:00 ETAmgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and ...


Jul 12, 2018, 11:24 ETGala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx™ System to Treat Chronic Bronchitis

Gala Therapeutics (Gala) today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval ...


Jul 12, 2018, 09:00 ETAbbott Receives FDA Approval for Next-Generation MitraClip® Device to Treat People with Leaky Heart Valves

Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a next-generation version of its leading ...