News by subject: FDA

IONETIX, a leading cyclotron technology and isotope manufacturing company, is pleased to announce the FDA approval for N-13 Ammonia manufacturing at Adler Institute for Advanced Imaging in Jenkintown PA. Adler Imaging has been the leading independent...

The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of...

Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S....

Meridian Bioscience, Inc. , a provider of diagnostic testing solutions and life science raw materials, today announced that their Revogene® SARS-CoV-2 assay was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration...

A.D.A.M. announces the launch of their Regulation Crowdfunding campaign on the StartEngine platform to finance the FDA required animal trials for non-metal personalized 3D-printed bone implants.  A.D.A.M. was founded in 2019 and, since then, has...

Today, Withings, pioneers of the connected health revolution, begins U.S. sales of ScanWatch, its award-winning and most advanced health wearable to date....

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for...

INOVIO , a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced that the U.S. Food and Drug Administration...

Seelos Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted...

Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved conditions, today announced the U.S. Food and Drug Administration (FDA) approval...

STOCKHOLM, Nov. 8, 2021 /PRNewswire/ -- Implantica AG (publ) today announces feedback from its third pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the approval of RefluxStoptm. FDA indicated its willingness to accept a...

Tris Pharma, Inc. (Tris) announced today that the U.S. Food and Drug Administration has approved Dyanavel XR (amphetamine), extended release once-daily tablets, CII, for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6...

Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1144 as a treatment for...

The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual...

UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral...

MIM Software Inc. announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for additional automatically segmented contours and local deployment for Contour ProtégéAItm, its robust AI auto-contouring solution....

OS Therapies, a research and clinical-stage biopharmaceutical company whose lead program uses OST-HER2 (Listeria monocytogenes) is being developed for therapies to treat and cure Osteosarcoma (OS), today announced the U.S. Food and Drug...

Insightec®, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the U.S. Food and Drug Administration (FDA) has approved the Exablate® Neuro for treating...

Renew Bioscience, a commercial stage medical technology company, announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the Cerezen® Device, a novel treatment for Mild Cognitive...

GeneVentiv Therapeutics, a pre-clinical gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to GENV-HEM for the treatment of Hemophilia A or B with or without inhibitors....

Nova Mentis Life Science Corp. ("NOVA" or the "Company"), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce that the U.S....

BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a Phase 1 clinical trial of...

Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature....

TCI Co., Ltd. has long been engaged in the research and development of banana peels and banana stamens, and finally passed the US FDA NDI approval in the middle of this year, becoming the world's first banana NDI. It is an important milestone for...

Novartis announced today that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients...

Erchonia, the World Leader in Low Level laser Technology announces that on October 22, 2021, they have received their latest 510(k) statement from the U.S. FDA based on level 1 blinded and controlled clinical trials. 510(k) #211186 The new FDA 510(k)...

Theseus Pharmaceuticals, Inc. ("Theseus"), a biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, today announced U.S. Food and Drug...

Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), today announces the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC43F, a...

Allergan, an AbbVie company, today announced the U.S. Food and Drug Administration (FDA) approval of VUITYtm (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults....

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA's thorough and...

Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the leva® Digital...

Neuroene Therapeutics announced that the FDA has granted orphan drug designation for the company's proprietary compound: NT102. NT102 was developed as part of a novel patented platform of mitochondrial and neuroprotective chemicals for the treatment...

ImmunoForge (Co-CEOs Sung-Min Ahn, Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 which is in development for treatment of Duchenne Muscular...

HUYABIO International (HUYABIOtm), the leader in accelerating global development of China's pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to...

The Breakthrough Device Designation is an FDA designation granted to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Since the inception of the Breakthrough...

Vitti Labs (www.vittilabs.com), an AATB Accredited Tissue Bank focused on Life Science Research, Development and Manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND)...

Sibel Health, an award-winning medical technology company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, announced its first 510(k) clearance from the U.S. Food and Drug Administration for the ANNE® One...

Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic tool for the early detection of cavities that are often not picked up by X-rays. The Ortek-ECD® is a breakthrough electronic...

Anitoa Systems, LLC., a Silicon Valley biotechnology company and market leader in rapid, portable molecular testing hardware, today announced its Maverick line of qPCR instruments have received US FDA registration and device listing as class II...

Precigen, Inc. , a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New...

Alkermes plc  today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in...

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), and Clearside Biomedical, Inc. ("Clearside"), a biopharmaceutical company revolutionizing the...

Naviswiss, a Swiss-based medical technology company receives clearance from the FDA to market Naviplan in the United States. Naviplan is a digital pre-operative planning application enabling orthopedic surgeons to perform navigated CT-based total hip...

Padagis today announced the FDA approval and launch of an AB-rated generic version of Doxil® (Doxorubicin Liposome Injection) through its partnership with Ayana Pharma Ltd. Doxil® Liposome Injection is an anthracycline topoisomerase inhibitor...

Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the clinical trial of PD-L1/TGF-? dual-targeting antibody (GT90008)...

Castle Creek Biosciences, Inc., a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options,...

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option Only biologic medicine approved for children with oral...

Cognetivity Neurosciences Ltd. (the "Company" or "Cognetivity") today announced that it has received notification from the US Food and Drug Administration (FDA) that its 510(k) submission for the CognICA Integrated Cognitive Assessment (ICA) has...

 ? A potential cure for HIV, developed by pioneering research scientist Dr. Serhat Gumrukçu, Director of the Seraph Research Institute (SRI), and his team have successfully completed the Pre-Investigational New Drug (IND) process for the U.S. Food...

The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be...