News by subject: FDA

The maker of NexGard® (afoxolaner), the #1 dog-preferred oral flea and tick protection1, introduces the latest addition to its feline portfolio ? NexGard® COMBO, new broad-spectrum parasite protection specially formulated for feline patientsNexGard®...

YourBio Health, Inc, the developers of the world's first virtually painless push-button blood collection device, announced today that TAP®...

Medtronic plc , the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its MiniMedtm 780G system with the Guardiantm 4 sensor requiring no fingersticks while in SmartGuardtm technology?. This...

Devices not cleared by the FDA are being sold in the USA! Buying non-FDA cleared devices can cause injury. Spa Sciences launches LEXI after receiving FDA clearance for effective treatment. IPL devices are considered medical devices and have rigorous...

Maxtec, a global leading manufacturer of respiratory care products, is excited to announce the launch of its newest device, the MaxO2 ME+p. This device is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the...

Watkins-Conti Products, Inc. ("Watkins-Conti"), a healthcare company that develops solutions for often-overlooked issues affecting women at every stage of life, announced today that it has successfully completed a clinical trial studying the safety...

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration...

New insights from leading portfolio demonstrate ongoing commitment to improving outcomes and experiences of those living with epilepsy and rare epileptic syndromesData will showcase further insights into the potential of UCB's generalized myasthenia...

Noctrix Health announced that the U.S. Food and Drug Administration (FDA) has granted its De Novo request for the NTX100 Tonic Motor Activation (TOMAC) System to treat symptoms of moderate-severe RLS and improve sleep quality in patients refractory...

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company's new Curian® Shiga...

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the company's...

Zucara Therapeutics Inc., ("Zucara" or the "Company") a diabetes-focused life sciences company developing the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced that the U.S. Food...

Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES)...

VGI Medical, LLC announces it has received 510(k) clearance from the United States Food and Drug Administration to market the transfixing SiJoin®  Triangular Trabecular Titanium (T3) Implant System. The SiJoin®  T3 System is the next evolution of the...

Global biotechnology leader CSL Behring today announced the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20%...

JanOne , the biopharmaceutical innovator specializing in non-addicting painkillers and new treatments for the causes of pain, has completed a successful pre-IND meeting with the FDA regarding Jan123. Jan123 is the company's unique oral delivery of...

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced it received U.S. Food and Drug Administration (FDA) clearance for the next-generation Neuspera ultra-miniaturized...

HuidaGene Therapeutics (????; HuidaGene), a clinical-stage biotechnology company developing CRISPR-based programmable genomic medicine, announces that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has...

QULIPTA® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronicExpanded indication provides an additional treatment option for those with chronic migraine whose frequent...

Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce...

Lipella Pharmaceuticals Inc. ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant...

OrthoFX, a pioneer in the next generation of orthodontic aligners, today announced the U.S Food and Drug Administration (FDA) 510(k) clearance of their NiTime Aligners. OrthoFX's NiTime Aligner is the first aligner system that is explicitly designed...

This afternoon, the US Supreme Court issued an administrative stay of the April 7 order from Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas.  This administrative stay, which runs until midnight on April 19, is a...

NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has agreed to the planned Phase II study of NS-089/NCNP-02 for Duchenne muscular dystrophy.  NS-089/NCNP-02 is an investigational candidate for patients with Duchenne muscular...

Study met both primary and all key secondary endpointsMean percentage change from baseline in Eczema Area and Severity Index (EASI) score was -78.7% in 1.0% MH004 Cream-treated group compared to -46.7% in vehicle group79.6% individuals treated with...

Xandar Kardian, a Toronto-based industry leader in developing radar signal processing technology for presence detection and vital sign monitoring, has formally announced an integrated partnership with Caregility, an enterprise telehealth leader...

Medaica, a digital health company extending the capability of home diagnostics, today announced that the U.S. Food and Drug Administration (FDA)-cleared1 Medaica M1 Telehealth Stethoscope (M1) will be free of charge, starting with qualifying...

New Non-Invasive Treatment Significantly Reduces Excessive Underarm Sweating and Significantly Improves Quality of Life ? Including Reducing the Negative Impact of Excessive Sweating on Daily Activities ? After a Single In-Office Treatment FDA...

Fusion Pharmaceuticals Inc. , a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068...

Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that the Company has received agreement from the U.S. Food and...

Annalise.ai, the global radiology AI company, announced today that...

MilkMate Products, Inc. (www.milkmate.com), the Manhattan-based company on a mission to support and empower working moms and the employers who support them, announced that its breast pump and parts for its new turnkey breast pumping solution,...

Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally...

Magnolia Medical Technologies, Inc., announced today U.S. Food and Drug Administration (FDA) 510(k) clearance of 19 new Steripath® Micro configurations within the company's ISDD® product portfolio. This clearance provides hospitals with...

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...