News by subject: FDA

Kato Pharmaceuticals, a privately-held clinical stage biopharmaceutical company, today announced that the FDA has approved the company's investigational new drug (IND) application to conduct human studies using Resolv ERtm for the treatment of...

AN2 Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted...

The Center for Devices and Radiological Health at the Food & Drug Administration has determined that Bonalive® Orthopedics granules, made of a unique S53P4 bioactive glass, qualifies for designation as a Breakthrough Device. Proposed indications for...

Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced that they have received the "safe to proceed" letter from the U.S. Food and Drug...

Mirati Therapeutics, Inc. , a clinical-stage targeted oncology company today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung...

Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal...

Kairos Pharma, Ltd. ("Kairos"), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, today announced that it has received FDA approval to proceed with a Phase 2 clinical trial of ENV105 with...

Casio America, Inc., announced today that the U.S. Food and Drug Administration (FDA) has cleared the DZ-D100 DERMOCAMERAtm and the DZ-S50 scope for skin observation as medical devices. The DZ-D100 and DZ-S50 will be available in the U.S. on Casio...

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") , a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct...

CloudCath Inc., a private medical device company advancing real-time fluid analytics and remote monitoring of infectious diseases, announced today it received U.S. Food and Drug Administration (FDA) clearance for the CloudCath System, the world's...

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new...

Datar Cancer Genetics Inc today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra-Prostatetm' blood test to detect early-stage prostate cancer. This is the second test from the...

Avion Pharmaceuticals, LLC, an Alora Pharmaceuticals company, announced the commercial launch of DHIVY, the first and only carbidopa/levodopa (CD/LD) fractional tablet designed to be divided. Avion gained approval for DHIVY from the FDA in November...

Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense® E3 Continuous Glucose Monitoring...

IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent", HKEX: 01801), today jointly...

Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together...

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company announced today. Bebtelovimab can now be...

The U.S. Food and Drug Administration (FDA) held a public Oncology Drug Advisory Committee (ODAC) for sintilimab, which is under review for the first-line treatment of people with non-squamous non-small cell lung cancer (nsqNSCLC) based on the...

Esaote North America, Inc. is proud to announce the FDA approval of the Magnificotm Open MRI, a new open whole-body MRI system now available for purchase in the USA. The Magnificotm Open, was designed with the user in mind through customer feedback...

Evofem Biosciences, Inc., announced today that the U.S. Food and Drug Administration (FDA) has awarded "Qualified Infectious Disease Product" (QIDP) Designation to EVO100 (the investigational name for Phexxi® (lactic acid, citric acid and potassium...

Scopio Labs, provider of the world's first full-field digital cell morphology solution, today announced a $50M investment for its end-to-end hardware and software platform for digitizing, quantifying and analyzing hematology and other digital...

Allergan Aesthetics, an AbbVie company , announces the FDA approval of JUVÉDERM® VOLBELLA® XC for improvement of infraorbital hollows in adults over the age of 21.2 According to clinical trial data, 90% of subjects reported satisfaction through one...

CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational...

Synthetic Biologics, Inc. , a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced that VCN Biosciences, S.L.'s (VCN) VCN-01 received Orphan Drug Designation for...

atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational...

Check-Cap Ltd. (the "Company" or "Check-Cap") , , a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into...

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)...

Photocure ASA, The Bladder Cancer Company, announces U.S. Food and Drug Administration (FDA) approval of a new and improved Blue Light system to be used with Photocure's Cysview® product in Blue Light Cystoscopy (BLC®) procedures for the detection of...

Ascletis Pharma Inc. (HKEX: 1672) announces today the approval of the Investigational New Drug (IND) application by U.S....

Viatris Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%, the...

Lover, the digital therapeutic app for improving users' sex lives and treating sexual problems, is announcing today that the FDA has approved the app and it joins the FDA's Safer Technologies Program STeP. With this recognition, users of Lover can...

American Regent announces the introduction and availability of FDA-approved Vasopressin Injection, USP. Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines....

The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to...

Theseus Pharmaceuticals, Inc. (Theseus) , a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, today announced that...

AxioMed's lumbar viscoelastic total disc replacement PMA Module II was submitted to the FDA on January 28th, 2022. "The demand for disc replacement has been compounding over years in the USA, Europe and Australia and will J curve with the FDA...

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved an expanded label for CABENUVA (rilpivirine and cabotegravir) to be administered every two months for the treatment of...

Brand Institute is proud to announce its successful partnership with Moderna in naming their FDA-approved COVID-19 vaccine: SPIKEVAX®, the second COVID-19 vaccine to be fully approved by the regulatory agency....

AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced the launch of KardiaMobile Card, the slimmest, most convenient personal ECG device ever created. At the size of a standard credit card,...

Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of...

In the news release, Fifth Eye Receives FDA Clearance to Market AHI Systemtm, issued 31-Jan-2022 by Fifth Eye Inc over PR Newswire, we are advised by the company that the subhead should read "hemodynamic instability" rather than "hemodynamic...

The 2022 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award was presented to Martha Murray, MD, FAAOS, and her collaborators for outstanding clinical research related to musculoskeletal disease or injury. Dr. Murray and her...

Fifth Eyetm, a provider of intuitive real-time clinical analytics, today announced the FDA provided clearance to market its second generation clinical decision support software, the AHI Systemtm, to hospitals in the United States....

UK, med-tech company, Bedfont Scientific Ltd., is celebrating a brighter 2022 as the U.S. Food and Drug Administration (FDA) cleared its NObreath FeNO monitor for use in monitoring airway inflammation....

NovelMed Therapeutics announced today that its Investigational New Drug Application (IND) to initiate clinical trials of its NM8074 biologic has been cleared by the U.S. Food and Drug Administration (FDA). NM8074 is the first of the company's three...

B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that the company has received final approval by the U.S. Food & Drug Administration (FDA) for its new pharmaceutical manufacturing plant in Daytona...

Suneva Medical, Inc. ("Suneva" or the "Company"), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, today announced that the U.S. Food and Drug Administration (FDA) accepted...

SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for?SNIPR001. SNIPR001 is the company's first development candidate targeting E. coli in...

Mind Medicine (MindMed) Inc. , (NEO: MMED), (DE: MMQ) (the "Company"), a clinical-stage biopharmaceutical company developing psychedelic-inspired therapies for the treatment of brain-based disorders, announced today that the U.S. Food and Drug...

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced it received IND clearance from the FDA to begin a Phase 2 trial of its Multi-Characteristic Opsin...

Medtronic plc , a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration approval of its Intellistm rechargeable neurostimulator and Vantatm recharge-free neurostimulator for the treatment of chronic...