News by subject: FDA

GC Biopharma (006280.KS), a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License...

Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human...

Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter , nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second...

In the news release, FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy, issued 27-Jul-2023 by NS Pharma over PR Newswire, we are advised by the company that the second paragraph, last...

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a...

Proprio, a Seattle-based surgical technology company, today announced that it has secured $43 million in Series B funding from new and existing investors. The capital fuels commercialization to address significant demand for Proprio's AI-driven...

NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy....

Today, UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. The UltraSight real-time AI...

In the news release, Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures, issued 26-Jul-2023 by Octapharma USA over PR Newswire, we are advised by the company...

CartiHeal Ltd., developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today announced its first commercial implantation of Agili-C in the US by Dr. Ken Zaslav, a specialist in...

The importance of accurate temperature taking has not changed since the advent of COVID-19 and is essential with the approach of cold and flu season.  For more than 20 years, Exergen Corporation has responded to that need by manufacturing the Exergen...

Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation...

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) has cleared Premier® HpSA® FLEXtm for the diagnosis of H....

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to...

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for...

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in...

EpiBone has received Investigational New Drug (IND) clearance from the FDA to begin testing its lab-grown knee cartilage in humans. The treatment, known as an engineered allogenic osteochondral graft, has shown promise in pre-clinical studies and...

Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease and improve patients' lives, today announced that the U.S. Food and Drug Administration (FDA) granted Investigational New Drug...

Nesa Medtech (Nesa), a private medical device company addressing clinical unmet needs for patients with symptomatic uterine fibroids, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's...

BD (Becton, Dickinson and Company) Chairman, CEO and President Tom Polen issued the following message regarding the U.S. Food and Drug Administration (FDA) 510(k) clearance for the updated BD Alaristm Infusion System:...

BD Alaristm Infusion System is the only modular and most comprehensive infusion system on the U.S. market that includes large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring, auto-identification, dose...

RYSTIGGO is now commercially available by prescription in the United States for adult patients with gMG who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1RYSTIGGO is the first and only...

Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML)...

SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on July 19 that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development. SNB-101 is the world's...

The maker of HEARTGARD® Plus (ivermectin/pyrantel), the #1 vet-recommended and #1 dog-preferred real beef chew,1, 2 introduces the latest innovation in its portfolio ? combination parasite protection for dogs in a single, monthly, beef-flavored soft...

The Clinical Neurological Society of America released a new expert-led clinical proceedings paper, "Rett Syndrome: A Devastating Neurodevelopmental Disorder." FDA approval of the first medication for Rett syndrome elevates the need for further...

Insightec continues to lead the Focused Ultrasound market with new FDA approval of five-year data demonstrating efficacy for Essential Tremor, without progressive or delayed complications Significant and sustained tremor improvement at five yearsNo...

Harmony Biosciences Holdings, Inc. ("Harmony") , a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, has successfully completed an End-of-Phase 2 meeting with FDA...

MediView XR, Inc., a leading clinical augmented reality med-tech company, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its XR90 augmented reality-based surgical visualization and navigation...

The results of the multicenter, international PROMISE clinical trial demonstrate that gadopiclenol provides similar lesion visualization and contrast enhancement at a gadolinium dose of 0.05 mmol/kg versus a full dose of gadobutrol (0.1 mmol/kg).[i]...

Dignity Health-GoHealth Urgent Care administered what is believed to be the world's first FDA-approved respiratory syncytial virus (RSV) vaccination at its Cole Valley location today. Peggy Dracker of San Rafael, CA, received the immunization from...

Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, announced today it is expanding its headquarters in the Denver metro area to support the growth of its products, which include the...

Synaptogenix, Inc. ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that it entered into an agreement with Cleveland Clinic to conduct a...

Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, today announced that it has received approval from the Food & Drug Administration ("FDA") for a protocol change in its Phase 2a clinical trial of HT-001. Participants will apply...

In 2018, inspired by John McCain's courageous battle with glioblastoma (GBM), a bipartisan group of senators passed a resolution to focus the nation's attention on GBM, which is the most common, complex, treatment-resistant, and deadliest type of...

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV)....

Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, announced today that the Company's independently developed and produced disposable MWA...

Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in...

Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy? the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral...

Perrigo Company plc , a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opill®, a progestin-only daily oral contraceptive, for over-the-counter use for all ages. Opill® is...

AlloSource®, one of the largest allograft providers creating innovative cellular and tissue products to help surgeons heal their patients, today announced the U.S. Food and Drug Administration's 510(K) clearance of AceConnex Pre-Sutured Fascia for...

Urotronic, Inc. today announced it has received U.S. Food and Drug Administration (FDA) approval of its Optilume® BPH Catheter System, a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary...

BioCareSD is excited to announce the addition of ROCTAVIANtm, RYSTIGGO®, and VYVGART® HYTRULO to their rapidly growing portfolio of life-saving specialty therapies. Each product recently received approval from the U.S. Food & Drug Administration...

Renibus Therapeutics, Inc., ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted...

Kabrita USA, a division of Ausnutria, a company with over 75 years of infant formula expertise and experience worldwide, announced today that its Kabrita Goat Milk-Based Infant Formula (0-12 months) meets all the US Food and Drug Administration's...

New Indication Expected to Increase Treatment Options of Heavy Menstrual Bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception...

A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) showcases nine critical oncology treatments by highlighting the vital role of post-approval research and development (R&D) in advancing cancer treatment options and...

"We are happy to broaden our ventilator product offering for the US market", says Elin Frostehav, President Acute Care Therapies at Getinge. "This significantly increases our addressable ventilation market in the US, by now being able to target the...

NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Rare Pediatric Disease Designation to NS-089/NCNP-02 (brogidirsen) an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44...

BioArctic AB's (publ) partner Eisai announced today that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics License Application, sBLA, supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL...