News by subject: FDA

RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vectorCommercial-scale cGMP material from the REGENXBIO Manufacturing...

FDA has accepted an Interim Analysis Plan for an IDMC to assess clinical outcome when 36 patients are enrolled in the Company's Ph2b clinical trial of ibezapolstat in patients with CDIA scientific poster highlighting a novel pharmacologic property of...

Reach Neuro, Inc., a neurotechnology company giving control and independence back to people with debilitating neurological disorders, announced today that it has been granted a Breakthrough Device designation by the U.S. Food and Drug Administration...

Danco Laboratories strongly disagrees with unprecedented preliminary injunction issued by US District Judge Matthew Kacsmaryk in The Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Administration, et al. The lawsuit seeks to overturn...

Torrent Pharma has begun shipping the generic version of Xeris's Keveyis® (dichlorphenamide), 50mg tablets, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Torrent is distributing the...

NIH Blueprint MedTech grant supports the development of a medical device that can improve the treatment of apnea in preterm newborns.Every year, about 1.6 million preterm newborns experience apnea of prematurity, or episodes where they stop breathing...

Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena?a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women...

Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. "This approval marks a key milestone for our company. The FDA...

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted the Biologics License...

Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation....

Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced its receipt of additional United States Food and Drug Administration (FDA) clearances...

Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND)...

Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to initiate a Phase 2 clinical trial of BSI-045B, an...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. today announced the U.S. Food and Drug Administration (FDA) has granted PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) accelerated...

Marking a significant advance in infant safety, the U.S. Food and Drug Administration (FDA) has given De Novo approval to Happiest Baby's SNOO Smart Sleeper. This is the first time the FDA has given De Novo approval to a product designed to keep...

Leica Biosystems today announced the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing customers with a high-performing IHC Mismatch Repair (MMR) option when screening colorectal cancer patients for the...

HuidaGene Therapeutics (????; HuidaGene), a global clinical-stage biotechnology company focusing on developing genomic medicine, announces that the US. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for HG004,...

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 the United States (U.S.) Food and...

P-Cure announced today clearance of its Adaptive Proton Therapy Solution by the FDA for sales in the USA. P-Cure, an Israel-based high-med-tech company,...

CMP Pharma announced today that in order to mitigate drug shortage concerns, the FDA's CDER Office of Compliance has granted a shelf life extension for CMP Development LLC Potassium Phosphates Injection (NDA 212121). Providers and patients that have...

American Regent announces the launch of sulfite-free Epinephrine Injection, USP.1 Epinephrine Injection, USP, is indicated for...

The world is becoming more aware of the importance of using recycled packaging to protect the environment, in line with the principles of a circular economy where post-consumer recycled PET (PCR PET) plastic resins are used in packaging in the food...

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its QScout RLD rapid-result hematology system intended to report white...

Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche's novel, siRNA therapy to treat preeclampsia. Preeclampsia...

Piramal Pharma Solutions, a patient-centric Contract Development and Manufacturing Organization...

Bioretec Ltd, a pioneer in bioresorbable[1] orthopedic implants, has today announced receiving the market authorization of the U.S. Food and Drug Administration (FDA) for its pioneering RemeOstm trauma screw to be used for healing of bone fractures...

Bioretec Ltd., a pioneer in bioresorbable[1] orthopedic implants, has today received market authorization for its RemeOstm trauma screw in the U.S. The RemeOstm trauma screw is the first and currently only bioresorbable metal implant approved by the...

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...