News by subject: FDA

ImmVira announced that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ("NMPA") for Phase I clinical trial in China on March 29, 2023. Previously, MVR-C5252 also...

The U.S. Food and Drug Administration (FDA) announced Wednesday that the agency has approved Naloxone Nasal Spray for over-the-counter use. Naloxone is a key medication in preventing opioid overdose deaths, which have risen significantly in recent...

PathoVax LLC ("PathoVax"), a biotech company focused on developing a universally preventative Human Papillomavirus (HPV) vaccine - "RGVax", today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the...

Dr. Lori Teller, AVMA President, will testify before the House Energy and Commerce Subcommittee on Health on March 30, 2023, at 9:00 AM ET to discuss the importance of reauthorizing the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug...

CoreLink, LLC , a leading designer and manufacturer of innovative spinal implant systems announced today the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Siber® Ti Sacroiliac Joint Fusion System. The Siber Ti System...

EpicentRx, Inc. ("EpicentRx"), announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to RRx-001, a direct NLRP3 inhibitor and Nrf2 upregulator with anti-inflammatory and antioxidant properties, for the...

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food...

Vanda Pharmaceuticals Inc. (Vanda) today announced a win in its jet lag FOIA litigation against the FDA. On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records...

OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP"). According to the terms of the...

ExtriCARE USA, is pleased to announce that its innovative extriCARE 3000 pump has received FDA approval for use in the United States. The extriCARE 3000 pump is a state-of-the-art medical device designed to provide versatile and effective wound care...

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam:...

Getinge's iCasttm covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease. Iliac arterial occlusive disease is a type of peripheral...

Neurelis, Inc., announced the first two cohorts dosed in the investigational clinical trial of NRL-1049, a Rho kinase (ROCK) inhibitor, a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by...

ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with...

CodeSteri, a leading provider of disinfection solutions, is proud to announce the launch of PlaClin-M, a revolutionary device designed to help ensure a clean and safe environment in offices, commercial establishments, and public spaces. CodeSteri...

Genomadix, based in Ottawa, Canada, announced today the US Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its "Genomadix CubeTM CYP2C19 System" (Cube CYP2C19 test), an automated sample-to-result PCR test. The Cube...

The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan®, the non-invasive liver management technology by Echosens....

Alio, Inc., a medical technology company reinventing the management of chronic disease, announced its latest FDA clearance. The company's second clearance added three additional metrics to its groundbreaking remote patient monitoring platform -...

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced its 2022 Annual Results. Business Highlights Zevor-cel (CT053)...

AbbVie today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with...

Wesper, a leading sleep testing and management service provider, announced today that it received a third clearance from the U.S. Food and Drug Administration (FDA) for its next-generation device. The new device positions Wesper as the first and only...

AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel approach to medicine, today announced that the Centers for Medicare and Medicaid Services (CMS) established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code...

GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental disorders, announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its flagship product, Prism for...

Brainomix, the AI-powered medtech solutions company, today announced that its Brainomix 360 e-ASPECTS tool for stroke has received FDA clearance, enabling the Oxford-based company to deploy its cutting-edge stroke...

Mallinckrodt plc , a global specialty pharmaceutical company, today announced that an abstract highlighting results from a retrospective analysis evaluating the corticosteroid-sparing effect and reduction of...

Advamedica Inc., a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-Surgi has become first and only chitosan based...

Danco Laboratories forcefully defended the approval of Mifeprex® in a four-hour hearing held in federal court in Amarillo, Texas in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The plaintiffs in this case raise a series of...

When the FDA approved Rebyota, a new class of Clostridioides Difficile (C.diff) treatment, Ferring Pharmaceuticals ushered in the first significant breakthrough doctors treating the disease have seen in years. Rebyota falls in the class of therapy...

Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for...

Telix Pharmaceuticals Limited  today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable...

Telix Pharmaceuticals Limited  today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable...

Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at risk of developing acute brain failure,...

TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insightstm for...

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 for its second generation point of care (POC) test. The Visby Medical Sexual Health test is a fast,...

TrueBinding, Inc.? a clinical-stage biotherapeutic company creating new and exciting molecules for applications in neurodegenerative and other disease areas with great unmet needs? announced today that the company has been granted a Type B...

HYFTOR® (sirolimus topical gel) 0.2%, indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and pediatric patients 6 years of age and older, is now covered by Medicare in Texas, Florida, New...

Biocoat Incorporated, a specialty manufacturer of hydrophilic biomaterial coatings, coating services, and coating equipment for medical devices, today announced that its HYDAK® UV coating is now being used on two medical devices that have been...

Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today that the U.S. Food and Drug...

Servier, a global pharmaceutical group, announced today that the Phase 3 INDIGO clinical trial investigating vorasidenib in monotherapy for patients with residual or recurrent IDH...

Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Teriflunomide to its portfolio of oral medications. The drug is formulated as a film-coated tablet. Accord's Teriflunomide is therapeutically equivalent to Sanofi Genzyme's...

PADM Medical Group of Companies (PADM Medical Canada and PADM Medical USA), a global leader in the design and development of sustainable medical consumables and eco-friendly sustainable...

Sooma Medical, a medical device company based in Finland, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device to treat depression. This...

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.This additional approval will...

Eli Lilly and Company today...

Convatec has received clearance from the U.S. Food and Drug Administration for its InnovaBurn® placental extracellular matrix medical device for management of complex surgical wounds and burns, including partial-thickness second-degree burns....

Neuro20 Technologies Corp, a wearable medical device manufacturing company specializing in the development of next-generation wireless wearable textiles to treat neuromuscular injuries and disease while enhancing human performance...

In a first-in-human, compassionate use case approved by the U.S. Food and Drug Administration, University of Michigan Health Interventional Radiologists Dr. David M. Williams and Dr. Minhaj S. Khaja successfully used VeinWay's Traversa for venous...

A new white paper from the Clinical Neurological Society of America explains how misconceptions about the FDA's Accelerated Drug Approval Program could undermine patients' timely access to novel medications ? and why collaboration and greater...

Perrigo Company plc , a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and...

MediPharm Labs shares progress on clinical trials, including the provision of clinical trial materials and research support to multiple partners.Research support consists of both product and services for partner studies across various...