News by subject: FDA

SyntheticMR announced today that their next-generation imaging solution with isotropic resolution, SyMRI 3D, has received FDA 510(k) clearance for clinical use in the United States. SyntheticMR is proud to announce that its next-generation imaging...

Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies,...

Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for...

Inspira Technologies OXY B.H.N. Ltd.  (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31, 2023. Dagi Ben-Noon, Chief Executive...

OPSYNVI® combines two proven treatments with established efficacy and safety profiles into one tablet to be taken once daily, offering an option that helps to support the implementation of clinical guideline recommendations for early use of...

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19...

-       The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FR?)-positive, platinum-resistant ovarian cancer (PROC) -       Data...

Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), welcomed today's decision by the Food and Drug Administration (FDA) to approve DUVYZATtm(givinostat) a histone...

Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat...

BIOTRONIK has been granted Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolvetm below-the-knee resorbable magnesium scaffold (BTK RMS)....

Global law firm Greenberg Traurig, LLP expanded its Health Care & FDA Practice in the firm's Houston office with the addition of Nicholas J. Diamond. Diamond joins the firm from Jackson Walker, where he...

Human Immunology Biosciences (HI-Biotm), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted...

Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib, to treat immune thrombocytopenia (ITP). Oscotec has successfully completed phase 2 study in patients with...

Oobli, the leading global sweet protein platform known for its healthy sugar alternatives, today announced it has received the "No questions" letter from the US Food & Drug Administration (FDA), accepting the Company's conclusion that the Oubli Fruit...

Rafa Laboratories, LTD., a leading manufacturer of Emergency Medical Solutions, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of...

The Aesthetic Society, the leading authority on aesthetic plastic surgery, and The Aesthetic Foundation, the philanthropic research and education arm of The Aesthetic Society, proudly announce the launch of the American Registry for Breast Implant...

PTC Therapeutics, Inc. today announced the submission of a BLA to the U.S. FDA for Upstazatm (eladocagene exuparvovec), a gene therapy for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. In addition, based on recent feedback...

inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA 510(k) clearance for its AI software module. The new AI module enables...

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early...

Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory...

Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called...

Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and...

Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOstm Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a...

Poseida Therapeutics, Inc. , a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...

Overjet, the world-leader in dental AI, today announced the launch of Overjet for Kids: the new standard of dental care for kids. It is the only technology cleared by the U.S. Food and Drug Administration (FDA) to detect, outline, and quantify tooth...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December...

Casio Computer Co., Ltd. announced today that the DZ-C100 COLPOCAMERA, which is designed for uterocervical observation and photography in gynecological settings, and the CST-100M camera stand are released in the US, Australia and New Zealand today....

Astellas Pharma US, Inc.  (TSE: 4503, President: Mark Reisenauer, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA®...

Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This...

Today, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or...

Today, Getinge announces the U.S. Food and Drug Administration's (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company's endoscopic vessel harvesting (EVH) solutions. Designed with customer centricity top of...

Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final...

Verismo Therapeutics, a clinical-stage CAR-T company developing the novel KIR-CAR platform technology, today announced that it has activated a second clinical site for its STAR-101 Phase 1 clinical trial at The University of Texas MD Anderson Cancer...

CSL Seqirus, a global leader in the protection of public health, confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug...

Vanda Pharmaceuticals Inc. (Vanda) today announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA)...

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not...

Clear Guide Medical proudly announces the FDA clearance for the CLEAR GUIDE SCENERGY computer aided instrument guidance system, alongside the new TP Access Tool with SteriGRIDtm....

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for use in professional and home testing settings....

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased...

Today, Allergan Aesthetics, an AbbVie company , announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first...

Analog Devices, Inc.  today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sensineltm Cardiopulmonary Management (CPM) System. The compact wearable device is a non-invasive, remote management...

PhotonPharma, a biotechnology company dedicated to revolutionizing cancer treatment, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical study for the treatment of Stage...

Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today that it has received Fast Track designation from the U.S. Food...

Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of...

Today, the pharmaceutical company Perrigo announced that it will begin shipping the first ever FDA-approved over-the-counter daily oral contraceptive pill, Opill, to retailers across the country. This marks a historic advancement in access to...

Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe...

BioLineRx Ltd. , a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received...

Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration(FDA) on the 29th(local...

Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat...

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with...