News by subject: FDA

Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent attacks of...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for...

The US Food and Drug Administration (FDA) has granted over-the-counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to...

The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start...

Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer's and other diseases of aging, today announced clearance by the U.S. Food and Drug Administration (FDA) of the...

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScouttm rapid-result hematology...

Versameb AG ("Versameb"), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application...

Chemomab Therapeutics Ltd. (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory...

Brixton Biosciences, a clinical-stage life sciences company developing novel therapies for chronic and acute pain, is delighted to announce that its groundbreaking Cooliotm Therapy has received the prestigious Breakthrough Device Designation from the...

InMed.AI (InMed Prognostics Inc.), a pioneer in AI-driven predictive analytics using multi-modal data including text, signal, and image (US Patent No.11263749) and the creator of an end-to-end fully automated organ agnostic imaging platform,...

Zynex, Inc. , an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that it has submitted a 510(k) application to...

Karmanos Cancer Institute, the largest provider of cancer care and research in Michigan and part of McLaren Health Care, announced today that it will be the first provider in the country to offer patients the new FDA-approved TheraBionic P1 device...

Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies...

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced a significant milestone for the chronic rhinitis market. The Centers for Medicare and Medicaid Services...

Lipella Pharmaceuticals Inc. , a clinical stage pharmaceutical company addressing serious diseases with significant unmet need based in Pittsburgh, PA, announced today that it has been granted "Orphan Drug Designation" from the U.S. Food...

Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for...

Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily...

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter antigen test for COVID-19. ACON Laboratories' Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home...

BioCare today released a white paper on the Drug Supply Chain Security Act (DSCSA) and how companies can prepare for compliance with the U.S. Food and Drug Administration's (FDA) requirements to ensure all medications are genuine, uncontaminated, and...

MediView XR, Inc., a leading clinical augmented reality (AR) med-tech company, announced today the first inpatient utilization of its XR90 AR-based surgical visualization and navigation system since its 510(k) clearance from the U.S. Food and Drug...

Ascidian Therapeutics,...

Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27...

The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Zepboundtm (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent...

Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradisetm Ultrasound Renal Denervation (RDN) system...

Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), today announced that PPMD has provided $250,000 in funding to Rare Disease Research, LLC (RDR), to open a second...

Hoag Memorial Hospital Presbyterian announced the successful implant of the world's first dual chamber leadless pacemaker in a patient. The minimally invasive surgery was a success and marks a new era in cardiac care....

Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope's innovative Procedural Choreographytm technique, which uses positive virtual...

On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The...

POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). STELLAR Knee is the first clearance for POLARISAR, a company focused on creating a new category in Mixed...

Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its...

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Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following...

Novartis,...

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting interim results from the postmarket...

Orphan Drug Designation (ODD) is a status that provides 7 years of post-approval protection and exemption from filing feesRare Pediatric Disease Designation (RPDD) qualified the Sponsor at the time of registration for a salable, transferable priority...

Chimeric Therapeutics , an Australian leader in cell therapy, announced today that the U.S....

Signifying a monumental step forward in the domain of powered antibody therapies, SparX Biopharmaceutical Corp. proudly announces that its Investigational New Drug (IND) application for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody...

NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has been granted 510(k) clearance by the US Food & Drug Administration (FDA) for the prevention or retardation of disuse atrophy and muscle re-education to...

Integrum (publ) today announces that the company's OPRAtm Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US. The clinical study will be important for the future approval of the OPRAtm Implant...

Global biotechnology leader CSL and uniQure N.V. , a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the companies have received the 2023 Prix Galien USA Award in the...

Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), welcomed today's decision by the Food and Drug Administration (FDA) to approve AGAMREE® (vamorolone) a dissociative...

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Omvohtm (mirikizumab-mrkz) infusion...

Centinel Spine®, LLC, ("the Company")...

Cordance Medical, a pioneering medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, announces that its NeuroAccesstm device has been granted Breakthrough Device Designation by the U.S. Food and Drug...

RoadMap Technologies, a leading provider of data science and software solutions for the Life Sciences industry, today announced that RoadMap has expanded its HITRUST certified platform to support JSON-based De-identification, as well as FDA Clinical...

NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company today announced further alignment...

EOSolutions Corp. is thrilled to announce that the US Food and Drug Administration (FDA) has cleared the Thinline Introducer Sheath, a remarkable achievement swiftly following the successful launch of the revolutionary Dr. Banner Balloon Guide...

On October 26, 2023, Biosyngen's TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for...

As the first hearing aid manufacturer to be listed in China, JINGHAO MEDICAL has once again taken a historic step. On September 26, 2023, the self-fitting OTC hearing aid developed and manufactured by JINGHAO MEDICAL officially received FDA 510K...

Denti.AI, a pioneer in leveraging Artificial Intelligence for dental pathology detection, odontogram and periodontal charting automation, proudly announces the 510(k) clearance by the FDA of its innovative product, Denti.AI...