News by subject: FDA

NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and...

Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGOtm...

Breakthrough Device Designations are given by the U.S. FDA to expedite the review of technologies that can improve the lives of people with life-threatening or debilitating conditionsEach year, 2.8 million Americans will fail multiple depression...

Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults...

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") , a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company held a Type B pre-BLA meeting with the U.S. Food...

Healthy.io, the global leader in transforming the smartphone camera into a medical device, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home use of the Minuteful Kidneytm test. This marks...

Medical imaging technology company Adaptix Limited (Adaptix) has submitted a 510(k) application to the U.S. Food and Drug Administration for its first medical imaging product ("NeXt 3D-Ortho"), allowing the company to begin marketing its...

Brand Institute is proud to announce its work with Osmotica Pharmaceuticals in developing the brand name RELEXXII®. RELEXXII®...

Anthos Therapeutics, a clinical-stage...

Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with...

Renovia Inc. ("Renovia"), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women's health, announced today that the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System for...

Kazia Therapeutics Limited , an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib for the treatment...

Titan Pharmaceuticals, Inc. ("Titan" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application for a Phase 1 study of its six-month or longer subdermal...

*  Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as...

American Regent, Inc. and Provepharm Life Solutions are pleased to announce the availability of ProvayBlue® (methylene blue) Injection, USP in a 10 mL single-dose vial. ProvayBlue® is indicated for the treatment of pediatric and adult patients with...

Xoran Technologies announced the company's recent submission of an FDA 510(k) application for TRONtm, an open-bore fluoroscopy computed tomography (CT) for full-body point-of-care imaging. The potential new addition to Xoran's suite of imaging...

PreventionGenetics, a subsidiary of Exact Sciences Corp., announced today that it was recently granted marketing authorization for the POMC/PCSK1/LEPR companion diagnostic (CDx) genetic test as a Class II device by the Center for Devices and...

LiveMetric, a leader in medical wearable technology, today announced the launch of LiveOne, the world's first 510(k) U.S. Food and Drug Administration (FDA) cleared nano-sensor technology for monitoring blood pressure every...

Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate...

Kanna Health Ltd (Kanna Health) - Today, the World Intellectual Property Office has published Kanna Health's patent application covering the use of KH-001 as a treatment for premature ejaculation, entitled "Methods for delay of ejaculation in human...

Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT886 for the...

Leiters, a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations and pharmacy services, announced today it has joined a new coalition of diverse stakeholders to address drug shortages in the United States. The End Drug...

Clarius Mobile Health, a leading provider of high-definition wireless ultrasound systems, and ImaCor Inc, the hemodynamic ultrasound company, today announced...

Invictus Sterilization LLC., a Hickory, NC based provider of Hospital-Grade UV-C based surface and air sterilization products, announced today that the U.S. Food and Drug Administration (FDA) cleared its Aura Storm as a Class II ultraviolet medical...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or...

MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received an expansion to its FDA 510(k) clearance for the MolecuLight i:X® imaging...

MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received an expansion to its FDA 510(k) clearance for the MolecuLight i:X® imaging...

Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceutical company, announced that its fully owned subsidiary Glenmark Pharmaceuticals Inc., USA (Glenmark) has acquired the approved Abbreviated New Drug Applications (ANDAs) for...

Apyx Medical Corporation , the manufacturer of Renuvion®, a proprietary helium plasma and radiofrequency technology, previously announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the use of the Renuvion...

Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application for a Phase 2 clinical trial to determine...

Daewoong announced that the U.S. Food and Drug Administration (FDA) had approved the IND for the phase 2 clinical trial of DWN12088, a PRS (Prolyl-tRNA Synthetase) inhibitor for patients with idiopathic pulmonary...

CNS Pharmaceuticals, Inc. ("CNS" or...

Fusion Pharmaceuticals Inc. , a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's...

Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E...

OxfordVR's gameChange treats patients suffering from some of the most challenging Serious Mental Illness (SMI) conditions with automated Cognitive Behavioral TherapyFully automated and scalable, the platform helps solve the clinician shortage with an...

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare...

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 the use of OsteoAdapt SP in...

? Boehringer Ingelheim Animal Health announced today that the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has granted conditional approval of VETMEDIN®-CA1 (pimobendan), which is indicated for the delay of onset of...

Regulus Therapeutics Inc. , a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that the U.S. Food and Drug Administration (FDA) has granted...

Ardelyx, Inc. , a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA)...

Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT217 for the...

Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, today...

SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUStm) to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval...

Beginning Tuesday, June 21, Texas Children's Hospital will begin administering both the Pfizer and Moderna COVID-19 vaccines to children aged 6 months to 5 years, following FDA emergency-use authorization and recommendations for safe administration...

Conformal Medical, Inc., a medical device company developing next-generation LAAO technology, today announced the launch of the CONFORM pivotal trial with the enrollment of the first patients at two U.S. sites. The investigational device exemption...

- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and...

Kazia Therapeutics Limited , an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Kazia's paxalisib for the treatment of atypical...

Global Cord Blood Corporation ("GCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, is pleased to announce that Cellenkos, Inc. ("CLNK")...

MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance,...

Think Research Corporation ("Think" or the "Company"), a company focused on transforming healthcare through digital health software solutions, is pleased to announce its subsidiary, BioPharma Services Inc., ("BioPharma") has continued its record of...