News by subject: FDA

Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for OriCAR-017 for patients with...

Ascidian Therapeutics, a biotechnology company aspiring to treat human diseases by rewriting RNA, today announced that the U.S. Food and Drug Administration...

Abbott announced today that it received approval from the U.S. Food and Drug Administration (FDA)...

Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee Arthroplasty. This state-of-the-art system is redefining total knee arthroplasty with its...

The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully integrated image processing platform based on digiM's proprietary cloud technology. I2S, short for Image to...

Heron Therapeutics, Inc. , a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam)...

Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease,...

Medunik USA, member of Duchesnay Pharmaceutical Group (DPG) one of the few anchor companies selected by the Government of Canada for its Global Hypergrowth Project, is pleased to announce that Pheburane® coverage has reached another important...

Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the U.S....

Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced today that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a...

GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...

Circulus Holdings, PBLLC ("Circulus"), a producer of post-consumer resin (PCR) from recycled low-density polyethylene, has received a Letter of Non-Objection (LNO) from the U.S. Food and Drug Administration (FDA) for its Ardmore, OK facility....

On January 17, 2024, NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of NK010, the non-genetically...

Johnson & Johnson...

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...

Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which...

Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for...

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60...

Immunity Pharma, a clinical-stage neurology-focused biopharmaceutical company, today announced positive...

The first U.S. implantation of VasQtm since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC. Developed by Laminate...

Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device. This announcement comes on the heels of Bloomlife's...

Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced it has received agreement from the U.S....

Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), announced that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed...

Horizon Therapeutics plc, now part of Amgen, announced that on December 15, 2023, Health Canada approved UPLIZNA® (inebilizumab for injection)...

Halozyme Therapeutics, Inc. ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the...

PherDal Fertility Science, Inc., creators of the first and only sterile, at-home insemination kit, is now accepting pre-orders of its intravaginal insemination (IVI) device, following FDA class II clearance....

NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA reviewQIDP designation grants Priority Review and an additional 5 years of additional product exclusivity 3 million Americans develop complicated Urinary Tract...

AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and...

FDA's De Novo approval of BrainSee represents a major advancement in Alzheimer's diagnostics. Utilizing cutting-edge image processing and medical AI, BrainSee establishes a new standard for predicting progression from amnestic mild cognitive...

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently developed mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), RC88, has been granted Fast...

Endovascular Engineering ("E2"), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption (IDE)...

Carl Zeiss Meditec AG -- ZEISS Medical Technology announced today that the U.S. Food and Drug Administration (FDA) has approved the VISUMAX® 800 with SMILE® pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism....

Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced...

Neuralace Medical, Inc., an innovator in pain management technology, today proudly announces the FDA clearance of its groundbreaking product, Axon Therapy (mPNS), for the treatment of chronic Painful Diabetic Neuropathy (PDN). This landmark approval...

GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009)....

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PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by UCB to dispense ZILBRYSQ®, a new FDA-approved therapy for the treatment of adults with gMG who...

Ultromics, a patient outcomes-focused AI-driven health technology company with roots at the University of Oxford, UK, has entered into an agreement with Pfizer to support the validation and FDA clearance of its AI-based technology for the detection...

Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® FFS-LX: Lumbar Facet...

The Centre for Chinese Herbal Medicine Drug Development of Hong Kong Baptist University (HKBU) has developed a new drug using effective components of a Chinese herbal medicine, Chaenomelis Fructus, for the treatment of the rare disease, myofibrillar...

LASEROPTEK Co., Ltd., a developer, and manufacturer of world-class lasers for aesthetic and medical dermatology, proudly announces its strategic partnership with The Pinnacle Health Group. This collaboration affirms LASEROPTEK's dedication to...

Natural Cycles, the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural Cycles app as a form of birth control. Previously sold in Canada as a fertility tracker, the Natural...

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, today announced its plan to launch a single-use disposable blood oxygenation kit...

NOWDiagnostics (NOWDx), a developer of over-the-counter and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced they have submitted a De Novo Classification Request to the U.S. Food and Drug...

Medtronic plc , a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percepttm RC Deep Brain Stimulation (DBS) system. The rechargeable neurostimulator is the latest innovation in the...

Shuttle Pharmaceuticals Holdings, Inc. ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II...

Techsomed Medical Technologies LTD is thrilled to announce that FDA has granted De Novo clearance for its BioTraceIO, a groundbreaking ultrasound-based liver ablation software - designed for Tissue Response Prediction. As the first and only...

Qvintm, the biotechnology research company that developed the first and only healthcare service that collects menstrual blood samples as an alternative to traditionally collected venous blood draws, today announced FDA clearance of its Q-Padtm and...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its SGX945 (dusquetide)...

Caliway Biopharmaceuticals (Caliway) announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum's Disease. Dercum's...