News by subject: FDA

- Cochlear Limited , the global leader in implantable hearing...

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a...

X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This...

Scopio Labs, developer of Full-Field Digital Cell Morphologytm imaging and analysis platforms and a recognized leader in digital morphology, today announced that it has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for...

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based...

Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstimtm Spine Fusion...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products...

SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd., today announced the U.S. Food and Drug...

More hope for successfully combating some of the deadliest cancers. Lamassu Biotech is proud to announce its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products...

Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic...

Labcorp , a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox  PCR Test Home Collection Kit to aid in the...

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel airway clearance and ventilation solutions, is excited to announce the expanded indication granted to the BiWaze® Clear System. The...

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, the FDA authorized for marketing MMI North America, Inc.'s Symani Surgical System, indicated for use during certain...

BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027. BC2027, which is BioCity's second first-in-class antibody drug...

Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center became the first in the nation to use a novel pulsed field ablation (PFA) system to treat patients with paroxysmal and persistent atrial fibrillation,...

Cadrenal Therapeutics, Inc. , a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare...

C2Sense, Inc., experts in advanced optical sensing platforms and Princeton BioMeditech Corporation (PBM), a world leader in rapid, point-of-care (POC) diagnostics, announced today that they have secured a second National Institutes of Health (NIH)...

Peleton Surgical today announced that it has received FDA clearance (K240071) to market its innovative single-use surgical power driver. The costs and patient risk associated with re-usable surgical drivers represent a challenge for healthcare...

Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center became the first in the nation to use a novel pulsed field ablation (PFA) system to treat patients with paroxysmal and persistent atrial fibrillation,...

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for...

Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo...

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS® (edaravone) based on their assessment that the oral form of...

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

Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell...

Johnson & Johnson announced today that the U.S. Food...

Microbion Corporation today announced that the company has published results from its topical pravibismane...

UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug...

Haemonetics Corporation , a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...

IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercialising innovative cell therapy and antibody products, is pleased to announce that the Investigational New Drug (IND)...

Affinity Biosensors, a leading innovator in the field of healthcare diagnostics, announces that its groundbreaking LifeScale AST system has received FDA clearance. This milestone gives healthcare professionals an important tool for managing...

Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective...

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)...