News by subject: FDA

Viatris Inc. , a global healthcare company, and Ocuphire Pharma, Inc. , a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye...

Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a...

Gravitas Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System. This milestone signifies a major step forward in advancing...

Saluda Medical, Inc. ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug...

Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced that the United States Food and Drug Administration (FDA) has provided regulatory...

HoneyNaps, the leading-edge AI-based sleep disorder diagnosis software company, has announced that its SOMNUM AI sleep disease analysis algorithm has been approved by the U.S. Food and Drug Administration (FDA). AI and medical devices are a...

Prostate cancer management reached a new pinnacle of precision with Bot Image's ProstatID using Bi-parametric MRI (bpMRI). The Nebrasksa-based MRI medical device company has developed and is distributing a FDA trifecta-cleared, AI-driven medical...

Approval adds to the treatment options for the more than 35 million adults in the U.S. affected by chronic kidney disease (CKD)Jardiance® (empagliflozin) 10 mg tablets significantly reduced the risk of kidney disease progression and cardiovascular...

MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Fast Track Designation (FTD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia...

Via Nova Therapeutics, Inc., a biotechnology company focused on discovering and developing therapeutics to treat viral infections with significant unmet medical need, today announced the clearance of its Investigational New Drug (IND) application...

Tyber Medical, a leader in the medical device industry, is pleased to announce that it has received: FDA and MDR clearance for its...

Hepagene Therapeutics, Inc. a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its HPG7233, an agonist of Thyroid Hormone Receptor...

Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion...

Pulmatrix, Inc. ("Pulmatrix" or the "Company") , a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced the U.S. Food and Drug...

NeuroSense Therapeutics Ltd. ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that the European, Japan, and Israel Patent Offices have granted the Company a key patent relating to "Compositions...

Natural Cycles, the company that developed the world's first birth control app, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch. The integration...

B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy and pain management, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AQUAbase nX Reverse Osmosis System....

RedHill Biopharma Ltd....

Crown Aesthetics ("Crown"), a division of Crown Laboratories, Inc., is excited to announce the launch of its newest innovation, BIOJUVEtm, in the United Kingdom, Ireland and Germany, the largest aesthetic market in Europe. BIOJUVE is a novel skin...

Today, patient advocacy groups, the United Mitochondrial Disease Foundation (UMDF) and MitoAction shared reactions from a listening session with the U.S. Food and Drug Administration (FDA) regarding Pyruvate Dehydrogenase...

SmartCardia has received FDA clearance for its 7-lead real-time ECG monitoring patch and cloud platform. SmartCardia's 7L patch is easy-to-wear, cable-free, waterproof and can be used for continuous monitoring for up to 14 days....

Oscotec Inc. and ADEL Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a...

Wellysis, a spin-off company from Samsung SDS, has received clearance from the U.S. Food and Drug Administration (FDA) on August 30, 2023, to market its wearable electrocardiography (ECG) patch, S-Patch Ex, in the U.S. The product, which received...

USA News Group - Sufferers of many different ailments saw reason to grow their hope in 2022 when the US Food and Drug Administration (FDA) granted several approvals and new Fast Track designations towards the end of 2022 and into January of 2023. In...

Inspiratm Technologies OXY BHN Ltd.  (the "Company" or "Inspira Technologies"), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a...

Aesthetic IQ Clinic now offers Galderma's newest hyaluronic acid filler that was recently approved by the U.S. Food and Drug Administration (FDA) called Restylane® Eyelight. The undereye hyaluronic acid (HA) dermal filler, is the first and only...

Aston Sci. is proud to announce that it has received Phase 2 Clinical Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative cancer vaccine, AST-201, designed specifically for ovarian cancer. This...

CyGenica Limited, a dynamic biotech startup announced today a significant achievement in the battle against Glioblastoma Multiforme (GBM), a highly aggressive form of brain cancer. Dr. Nusrat J M Sanghamitra, Co-founder and CEO of CyGenica, revealed...

Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious...

Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system....

Limaca Medical ("Limaca") announced today that its Precision GItm Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration ("FDA"). This follows Limaca's receipt of FDA Breakthrough Device...

OnPoint Surgical, Inc., a member of a group of privately held OnPoint companies pioneering augmented reality (AR) technology and artificial intelligence (AI) for multiple verticals including spine, neurosurgical, orthopedic and robotic procedures,...

BioLineRx Ltd. (NASDAQ/TASE:...

Medivir AB , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir's partner Tango Therapeutics has received FDA clearance on its Investigational New Drug...

On September 9th, 2023, Biosyngen Pte Ltd (hereafter as "Biosyngen") announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for Phase I/II clinical trial of BRL03 for the treatment of lung cancer, gastric cancer and...

Citius Pharmaceuticals, Inc. ("Citius" or the "Company")  is pleased to announce the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company's Biologics License...

AdventHealth Dade City is the first hospital in Pasco County with the unique FDA-approved Enterra treatment. Enterra helps patients suffering from nausea and vomiting due to gastroparesis, an often chronic condition that affects the stomach muscles...

Harmony Biosciences Holdings, Inc. ("Harmony") , a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA)...

alveofit® (Roundworks Technologies Private Limited) is thrilled to announce that its groundbreaking product, alveoair® spirometer, has earned U.S. FDA clearance for distribution in the United States. Specializing in digital therapeutics for...

INOVIO , a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug...

Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration approval for the latest-generation WATCHMAN FLXtm Pro Left Atrial Appendage Closure (LAAC) Device. Designed to further advance the procedural performance...

DifGen Pharmaceuticals LLC ("DifGen") announced today that it has successfully completed USFDA audit of its manufacturing site in Florida, Aveva Drug Delivery systems ? the first audit after it's acquisition of this facility in April, 2023....

CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to...

Techsomed Ltd., a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO software intended to...

Viatris Inc. , a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the...

The Parenteral Drug Association, Inc. (PDA), today announced Pulitzer Prize winning journalist Dominic Gates of the Seattle Times will present, "The Devastating Impact of Design and Manufacturing Quality Lapses at Boeing" during the second plenary...

Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded use of RELiZORB® to children...

Mallinckrodt plc , a global specialty pharmaceutical company, today announced that its Specialty Generics segment, operating as SpecGx LLC, received approval on August 25, 2023 from the United States Food and Drug Administration (FDA) for its...

BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Legtm; its robotic prosthetic knee. This registration marks a...