News by subject: FDA

Superbrewed Food, Inc. has announced that its proprietary postbiotic cultured protein has achieved self-affirmed GRAS (generally recognized as safe) status. Superbrewed Food is believed to be the first company...

Today, the ACANA® pet food team announced ACANA® Indoor Entrée received FDA approval for hairball control. The FDA approval confirms ACANA® Indoor Entree helps control hairball with fiber from oat groats, miscanthus grass, lentils, chickpeas, and...

Alnylam Pharmaceuticals, Inc.  is pleased to announce that Health Canada has issued a Notice of Compliance (NOC) authorizing OXLUMOtm (lumasiran) injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary...

Ortek Therapeutics, Inc., a leader in developing and commercializing novel oral care technologies, today announced that the Brazilian Patent and Trademark Office has issued a patent covering the Ortek-ECD®, a revolutionary electronic cavity detection...

Nouscom, a clinical stage immuno-oncology company developing both off-the-shelf and personalized cancer neoantigen immunotherapies, today announced that Janssen Research & Development, LLC (Janssen) received U.S. Food and Drug Administration (FDA)...

NeuroOne Medical Technologies Corporation ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces that the U.S. Food...

Overjet, the leader in dental AI solutions for payers and providers, today announced that it received FDA 510(k) clearance for its Caries Assist, AI-powered dental caries detection and outlining software for chairside aid and patient...

IONETIX, a leading cyclotron technology and isotope manufacturing company, is pleased to announce the FDA approval for N-13 Ammonia manufacturing at their Miami, FL location to support CIRA (Center for Imaging and Research of America). CIRA has been...

RadNet, Inc., today announced that it has received FDA clearances for its DeepHeatlh Saige-DXtm mammography and Quantib® Prostate 2.0 MRI artificial intelligence ("AI") algorithms. Saige-DX: AI Mammography Diagnostic Software Saige-Dx, a more...

SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic...

Faron Pharmaceuticals Ltd. ("Faron" or "Company") Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies Phase 1 dose escalation study...

Inmagene Biopharmaceuticals ("Inmagene") announces that today the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton...

The U.S. Food and Drug Administration (FDA) approved...

Today, the U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was effective at improving blood sugar and was more...

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the...

Medtronic plc , a global leader in healthcare technology, today announced it received U.S. Food and Drug Administration (FDA) approval for the Onyx Frontiertm drug-eluting stent (DES). As the latest evolution in the Resolute DES family, Onyx Frontier...

Neurocrine Biosciences, Inc.  today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for valbenazine as a treatment for Huntington disease (HD). The treatment of chorea associated with HD is...

On World Fibromyalgia Awareness Day (May 12), the French startup Remedee Labs is announcing that the FDA has granted Breakthrough Device Designation to its endorphin stimulator for fibromyalgia patients. The FDA's Breakthrough Device program exists...

Stealth BioTherapeutics Corp , a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the US Food and Drug...

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress CoV-2 plus, a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19....

Eli Lilly and Company and Incyte announced today the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive...

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today the Investigational New Drug (IND) application approval of ASC22 (Envafolimab) by U.S. Food and Drug Administration (FDA) for the indication of immune restoration/functional cure of human...

LSPediA, one of the nation's leading providers of enterprise supply chain software and services in the pharmaceutical industry, today announced OneScan 5.3, the newest version of their flagship cloud solution suite servicing thousands of industry...

Abbott's multiplex test runs on its most advanced molecular PCR platform, the Alinitytm m system, which provides fast results in high volumes ? detecting four infections simultaneouslyTest provides a critically important tool as people return to...

CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA 510(k) clearance of the ECGenius EP Recording System. ECGenius, the...

Ilya Pharma AB (the Company), a clinical stage immunotherapy company today announced that FDA have cleared an IND for its lead candidate ILP100-Topical and that the Company is immediately accelerating preparations for large adaptive Phase 2 study,...

Agastiya Biotech and Vopec Pharmaceuticals announce that the US FDA has granted Orphan Drug Designations for Pancreatic Cancer and AML for its novel small molecule, AB001.  ...

Strados Labs, a medical technology company harnessing the power of smart sensors, machine learning and proprietary algorithms to provide early detection and predictions of worsening respiratory diseases, today announced it has received FDA Class II...

Suneva Medical, Inc. ("Suneva" or the "Company"), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, and partner Bimini Health Tech ("Bimini"), today announced that they have...

Oramed Pharmaceuticals Inc. , a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced it has completed patient enrollment for its Phase 3 ORA-D-013-1 study of...

Cue Health ("Cue") today became the first company to submit to the U.S. Food and Drug Administration (FDA) for full clearance of its molecular COVID-19 test for at-home and point-of-care use. FDA clearance would provide the public with a molecular...

Supernus Pharmaceuticals, Inc. , a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved an...

Limaca Medical ("Limaca") announced today that its Precision-GItm Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA")....

Axsome Therapeutics, Inc. , a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and...

IDEAYA Biosciences, Inc. , a synthetic lethality focused precision medicine...

Brand Institute is proud to announce its successful partnership with mAbxience developing the brand name ALYMSYS®, under which the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022 will be marketed by Amneal...

Inmagene Biopharmaceuticals ("Inmagene") announces that the U.S. Food and Drug Administration (FDA) has cleared drug candidate IMG-007, a monoclonal antibody against OX40, to proceed to Phase I clinical development. Inmagene is developing IMG-007 in...

The Muscular Dystrophy Association celebrates yesterday's approval by the US Food and Drug Administration (FDA) to ravulizumab (Ultomiris) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine...

Today, Xcardia Innovation Ltd., a private medical device company developing innovative cardiac pacemaker and defibrillator technology, announced the first-in-human use of its new Xtractor device in patients undergoing lead extraction procedures....

AbbVie (NYSE:...

ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its...

TransMedics Group, Inc. ("TransMedics") , a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has...

NOCIRA®'s hand-held device that uses gentle, controlled puffs of air in the ears for treating migraine attacks is now designated by the FDA as a "Breakthrough Device." NOCIRA is the first company to announce FDA's Breakthrough Device designation for...

Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-400945, a first in class...

Debiotech, a leading Swiss innovation company in the field of medical devices, announced today that the VersitmPD Cycler System, developed in close collaboration with its licensee Fresenius Medical Care, has received 510(k) clearance from the U.S....

Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV...

BIOTRONIK, Inc. announced today it has received U.S. Food and Drug Administration (FDA) approval of Renamic Neo, the company's state-of-the-art programmer for implanted cardiac rhythm management devices such as ICDs, pacemakers, and implantable...

X-Nav Technologies, LLC, a leading creator of image-guided and robot-assisted surgical products, announced that is has received clearance from the U.S. Food and Drug Administration to expand the use of its X-Guide® Dynamic Surgical Navigation system...

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct...

CoNextions® Inc. (www.conextionsmed.com), an innovator in tendon repair, is pleased to announce that CoNextions TR® Tendon Repair System has received FDA 510(k) Clearance.  Expected to launch in May 2022, the novel system addresses traumatic tendon...