News by subject: FDA

Harmony Biosciences Holdings, Inc. ("Harmony") has initiated its global Phase 3 registrational trial, the TEMPO study, to evaluate the safety and efficacy of pitolisant as a treatment for excessive daytime sleepiness (EDS) and behavioral symptoms in...

SpliSense, a clinical-stage biotechnology company focused on the development of transformative RNA-based therapies for pulmonary diseases including cystic fibrosis (CF), muco-obstructive diseases like COPD, asthma, non-CF bronchiectasis (NCFB) and...

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL...

Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other...

Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its...

WAT Medical Enterprise achieves a major milestone: HeadaTerm 2 receives the OTC clearance from the U.S. Food and Drug Administration (FDA), making it one of the only wearable anti-migraine devices that is available without a prescription in the U.S....

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgeryMore than 1.6 million people in the U.S. are affected by tricuspid regurgitation,1 which can...

Drawbridge Health, a healthcare technology company focused on reinventing the blood draw experience, today announced that its at-home, patented blood sampling device, NanoDrop, has received U.S. Food and Drug Administration (FDA) 510(k)...

IceCure Medical Ltd. ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k)...

Concept Medical has been granted 'IDE Approval' from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous...

Kelyniam Global and Fin-ceramica, Faenza S.p.a., makers of custom cranial implants, announced today that the NEOS Surgery Cranial LOOPtm fixation system has received 510(k) clearance from the FDA for use with Finceramica's...

The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), or concussionThe test produces lab-quality results in 15 minutesClinicians are now able to...

Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their...

Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug...

Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug...

Nested Therapeutics, a biotechnology company pioneering a next-generation precision medicine platform to address hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND)...

CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who...

Akebia Therapeutics®, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA)...

The PATHFAST hs-cTnI-II, a breakthrough high-sensitivity troponin assay developed for the PATHFAST Biomarker Analyzer, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new test will facilitate the accurate, rapid...

Medtronic plc , a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evoluttm FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic...

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...