News by subject: FDA

OnQuality Pharmaceuticals ("OnQuality"), a leading targeted oncology supportive therapy company dedicated to addressing unmet needs in oncodermatology and oncogastroenterology to improve the quality of life for patients receiving anticancer...

Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with...

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft tissue, is pleased to announce that...

Geneseeq announced that its multi-cancer early detection solution, CanScantm, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA)....

Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard. The additional certification confirms the company's...

AnX Robotica, a pioneering force in advanced gastrointestinal visualization technologies, is excited to announce the FDA clearance of NaviCam ProScantm. Through the rigorous De Novo Submission Process, the FDA has granted clearance for ProScan,...

CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY", has been granted 'Breakthrough Device...

Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and...

NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration...

Co-Diagnostics, Inc. (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular...

Dr. David Davtyan, a renowned surgeon and pioneer in weight loss surgery, is delighted to announce the FDA approval of ReShape Lifesciences' groundbreaking Lap-Band® 2.0...

Inspira Technologies OXY BHN Ltd.  (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced a significant advancement in its sensor technology by its team of...

Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer,...

Ionis Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has...

Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced 510(k) clearance of its next-generation RELiZORB® (iMMOBILIZED LIPASE) cartridge by the Center for...

The Barth Syndrome Foundation (BSF), the only patient advocacy organization dedicated to Barth syndrome and saving lives around the world through education, advances in treatment and finding a cure, today announced that it is petitioning the U.S....

Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug...

I.P. ONE, a leading Thai FMCG market leader, supports the concept of Circular Economy and Zero Waste by partnering with ENVICCO, a company within the GC Group, and ALPLA Packaging to introduce the "Vixol: Transformative Innovation for Sustainable...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB ("Calliditas") announced that the U.S. Food and Drug Administration (FDA) had approved Nefecon® delayed release capsules to reduce the loss...

Calliditas Therapeutics AB ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A...

ulrich medical USA, the pioneer in expandable corpectomy devices and a market leader in spine technology, today announced FDA clearance for expanded indications of the Momentum and Momentum MIS Posterior Spinal Fixation Systems. The expanded...

Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, announced that their sponsor client, CellVax Therapeutics Inc., has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug...

Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CAREtm Assay, intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial...

Bio-Techne Corporation today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCelleratetm GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture...

Parkhurst NuVision, a leading ophthalmic clinic and Glaukos have reached a significant milestone...

HuidaGene Therapeutics (????"HuidaGene") today announced the U.S. FDA granted Rare Pediatric Drug Designation (RPDD) to HG302, a novel CRISPR-Cas12 DNA-editing...

Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced that, its...

Avstera Therapeutics Corp, an oncology-focused biotech dedicated to addressing the large disease burden and significant unmet need of cancer patients, today announced the U.S. FDA clearance of its Investigational New...

Inspira Technologies OXY BHN Ltd. (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced that its CEO and the Company's President will attend the upcoming...

RNAimmune, Inc., a partner of Innoforce, announced the U.S. Food and Drug Administration (FDA) granted IND clearance for its RV-1770 Respiratory Syncytial Virus (RSV) mRNA vaccine. Innoforce congratulates RNAimmune on this significant milestone...

Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Distal Radius...

NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company today announced that its Investigational New Drug Application (IND) for the use of NRX-101, the company's patented combination of...

On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of...

GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years...

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV®...

Atopic dermatitis (or AD) is a heterogenous, inflammatory condition of the skin and is usually accompanied by itch, redness, and swelling. AD can have a significant impact on the patient's quality of life. While several biologic treatment approaches...

Mission Therapeutics ("Mission" or the "Company"), a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, today announces that the US Food and Drug...

Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics") today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ("FTD") by the U.S. FDA for the treatment of tenosynovial giant cell tumor ("TGCT")...

Medtronic plc , a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent...

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab. Tarlatamab is a potential...

Gravitas Medical Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a second Breakthrough Device Designation to Entarik, the innovative Enteral Feeding System. This award allows Gravitas Medical to accelerate...

Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced it...

Ro, the leading direct-to-patient healthcare company, announced today it has expanded its Body Program offering with the launch of Zepboundtm (tirzepatide) injection, the latest FDA-approved weight loss treatment from Eli Lilly and Company. Now,...

Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that the first two patients were...

BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company...

HEMGENIX® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years post-treatmentLong-term data continues to show a one-time...

Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion...

Inspira Technologies OXY B.H.N. Ltd.  (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, is pleased to announce the appointment of Dr. Dan Gorfil to its medical advisory...

Celltrion USA today...

cultivate(MD), a leader in medical device venture capital, is thrilled to announce that one of its portfolio companies, NSite Medical, has received FDA clearance for its groundbreaking AI-based scoliosis scanning application. This marks a significant...