News by subject: FDA

DCN Dx, specializing in IVD CDMO and CRO services, has launched Regulatory Affairs Services, a new solution designed to help clients navigate complex regulatory pathways efficiently and successfully. The new offering provides comprehensive support...

Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMENDtm Trans-Septal System for investigational device exemption (IDE) application to...

UCB, a global biopharmaceutical company, today announced that Epilepsia published findings from the final analysis of the long-term open-label extension (OLE) study evaluating the safety and effectiveness of FINTEPLA® (fenfluramine) in patients with...

For the thousands of patients in the United States requiring treatment for bone loss or defects caused by trauma or infections, Elute, Inc., a clinical stage company and emerging leader with a groundbreaking controlled and extended drug delivery...

GT Metabolictm Solutions, Inc., the world leader in magnetic surgery is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared a larger, 50mm MagDItm System magnet1 to complement the system's existing 40mm magnet.2 This...

Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval...

Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its CaRi-Plaquetm technology, an AI-assisted image...

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that acceptance has been received by Capricor Therapeutics, Inc. (Headquarters: California, USA, CEO: Linda Marbán, NASDAQ: CAPR) from the U.S....

Beckman Coulter Diagnostics, a clinical diagnostics leader, today announced that the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer, received 510(k) clearance from the U.S. Food and Drug Administration. The...

Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent...

SkinCure Oncology, the world leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT or IGSRT) for the treatment of nonmelanoma skin cancer, presented to dermatology patients as the...

Zimmer Biomet Holdings, Inc. , a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® Revision SoluTiontm Femur, a revision knee implant component offering an alternative for patients...

Ferring Inc. announced Health Canada has issued a Notice of Compliance, approving REBYOTA® (fecal microbiota, live), a novel first-in-class microbiome-restoration therapy indicated for the prevention of recurrence of Clostridioides difficile...

NEXTBIOMEDICAL CO., LTD, a leading developer of cutting-edge Devices, announced that its groundbreaking product 'Nexsphere-Ftm,' a resorbable microsphere for musculoskeletal pain embolization, has received the Breakthrough Device Designation from the...

Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, has received 510(k) clearance from the Food and Drug Administration (FDA) to expand the use of ROTIUM® Bioresorbable Wick to all tendon...

On March 06, 2025, GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has received clearance from the U.S Food and Drug Administration(FDA) for its...

As part of its ongoing efforts to ensure patients who need Wegovy® (semaglutide) injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg can access it, Novo Nordisk launched NovoCare® Pharmacy, a direct-to-patient delivery option that offers cash-paying...

Bioheng Therapeutics US LLC ("Bioheng"), a clinical-stage biotech company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug...

Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, is announcing the Food and Drug Administration (FDA) has approved the...

Inspiratm Technologies OXY B.H.N. Ltd. ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced positive results from the clinical study of its AI-powered HYLAtm blood sensor.  Inspira believes...

Levee Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted approval to initiate the ARID II (A Pivotal Study of VoRo UrologIc ScaffolD for the Treatment of Post Prostatectomy Stress Urinary Incontinence)...

Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all...

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the U.S. Food and Drug Administration (FDA) expanded its indication of ODACTRA® (House Dust Mite Allergen Tablet) for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or...

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its...

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its...

Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the Company's lead therapeutic candidate for Crohn's...

Arcuro Medical Ltd., ("Arcuro") today announced that it received FDA 510(k) clearance for its new SuperBall-RCtm system for use in rotator cuff repair procedures. Current rotator cuff re-tear rates following surgery can range from 20%-40% in...

Sobi® (STO: SOBI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant® (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic...

Sway Medical, Inc., the company that created the Mobile Concussion Management category, is proud to announce that it has received FDA 510(k) clearance as a Computerized Cognitive Assessment Aid for Concussion under Section 882.1471. This clearance...

Visby Medicaltm announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid...

ABANZA, a leader in advanced soft tissue repair solutions, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative WasherCaptm Mini fixation system. This breakthrough device is designed...

Adcendo, a biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, today announced that the U.S. Food & Drug Administration (FDA) has provided clearance of the IND application for a Phase...

Telix Pharmaceuticals Limited today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx...

Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company, announced today that it will release its annual 2024 financial results and provide a company update after the market closes on Tuesday, March 4, 2025....

Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its ColoSealtm...

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, today announced the U.S. Food and Drug Administration (FDA) has approved Surgifort® human milk fortifier (human, pasteurized) for term infants...

CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that the first patient has been randomized to and treated with the eShunt® System in its STRIDE clinical trial, a...

OrthoNovis, Inc is proud to announce that it has received U.S. Food and Drug Administration (FDA) clearance to market its innovative BPS Wrist Fracture System. www.orthonovis.com...

Precigen, Inc. , a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the US Food and Drug Administration (FDA) has accepted the company's biologics...

Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® COVID/Flu multiplex test. This innovative test represents...

For the one million people diagnosed with Parkinson's disease in the United States1, Medtronic plc , a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration (FDA) approval of BrainSensetm Adaptive deep brain...

Azitra, Inc. , a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2024, and provided a business update. FY 2024 and...

Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), a market leader in hemp extract wellness products, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its review of Phase 1 data and...

Insmed Incorporated , a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA)...

DeFloria, Inc., a collaboration between Ajna BioSciences PBC and Charlotte's Web Holdings, Inc. , announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for AJA001, an...

Hangzhou Viablife Biotech Co., Ltd., a leading innovator in biosynthesis and biofermentation technologies for food and dietary supplement ingredients, proudly announces that its highly-scalable biosynthesized Hydroxytyrosol has received "No...

Indivior PLC , a global leader in addiction treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved label changes for SUBLOCADE® including a rapid initiation protocol and alternative injection sites, marking a...

Co-Diagnostics, Inc. (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the...

Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. "The FDA is dedicated...

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has determined the shortage of Wegovy® and Ozempic® is resolved. The FDA's assessment confirms the U.S. supply of these prescription-only GLP-1 medicines now meets or exceeds...