News by subject: FDA

OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and...

Florida Cancer Specialists & Research Institute, LLC (FCS) today released a case study outlining the evolution of a newly FDA-approved first-line therapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The...

Promis Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to EarlyTect BCD as a non-invasive, urine-based diagnosis of bladder cancer from patients with hematuria. Promis...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan FDA has approved its Phase II IND application of...

Cooler Heads, a health tech company that has developed an FDA-cleared, portable patient-administered scalp cooling device to help cancer patients undergoing chemotherapy keep their hair, reports accelerated sales growth during its first year on the...

100% (18/18) MCO-010 patients experienced a clinically meaningful improvement in vision-guided mobility (MLYMT), near-field object recognition (MLSDT) or visual acuity (BCVA) (p=0.007 vs sham)94.4% (17/18) MCO-010 patients showed vision improvement...

Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that it received Breakthrough Device Designation from the U.S. Food and Drug Administration...

3M Health Care's innovative 3Mtm Veraflotm Therapy, with both 3Mtm Veraflotm Cleanse Choice Completetm Dressing and 3Mtm V.A.C. Veraflo Cleanse Choicetm Dressing, received the first-ever Food and Drug Administration (FDA) clearance for...

- NEONAVIA is a new, minimally invasive option designed to provide controlled needle insertion, accurate lesion targeting, and high tissue yield from technically difficult lesions as well as difficult to access pathology. - Commercial launch and...

Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18...

Apotex Corp. has expanded its oncology product portfolio with the launch of Bendamustine hydrochloride injection in the United States....

Ultromics, a leader in the field of artificial intelligence-powered diagnostics for heart failure, has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting cardiac amyloidosis....

CardieX Limited (CardieX, the Company), today announced its new arterial health monitor, the CONNEQT Pulse (Pulse), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the only vital signs monitor targeted at...

Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area.3...

Ionis Pharmaceuticals, Inc.  today announced that its partner Biogen has received U.S....

Today, ZEISS Medical Technology announced the U.S. Food and Drug Administration (FDA) has approved the CT LUCIA® 621P Monofocal IOL from ZEISS, an aspheric, monofocal, single-piece C-loop IOL. The IOL features the patented ZEISS Optic (ZO)...

Abbott's CentriMagtm Blood Pump, previously cleared for use up to six hours, now can be used to provide longer-term life support to critically ill patients, providing doctors more time to make critical care decisionsAbbott's CentriMagtm Pre-connected...

Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced its FDA cleared prostate cancer management platform, Unfold AItm, is being used for the first time in a commercial setting with patients...

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,...