News by subject: FDA

We are excited to announce that Bimini Health Tech has received FDA approval for the launch of our rebranded Puregraft Serene Breast Implants, marking an expansion of our global portfolio in plastic and reconstructive surgery. Through the acquisition...

MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan's De Novo request for BrainSee by...

Palatin Technologies, Inc. , a biopharmaceutical company developing first-in-class medicines based on...

United Imaging, a global leader in manufacturing advanced medical imaging and radiotherapy equipment, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) with the clearance of its uMR Jupiter 5T MRI system. This...

BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA Investigational Device Exemption (IDE) approval with conditions to commence enrollment in...

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable* biosimilar to Humira® (adalimumab), to...

Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today the U.S. Food and Drug Administration (FDA) has...

Neurocrine Biosciences, Inc.  today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults...

Eluminex Biosciences (Eluminex), a privately-held biotechnology company focused on the development of advanced protein therapeutics for vision-threatening diseases and dermal facial aesthetics announced the acceptance of their EB-105 IND application...

Integrity Orthopaedics, Inc., a company pioneering next generation solutions for soft tissue repair, has successfully closed on a Series B financing of $20.6 million. The financing was co-led by Piper Sandler Merchant Banking and an undisclosed...

INCOG BioPharma Services proudly announces that its sterile injectable manufacturing facility has received approval from the U.S. Food and Drug Administration (FDA) to produce a commercially approved drug product. The regulatory approval for its...

AEYE Health, the leading company for AI retinal imaging and diagnostics, is thrilled to announce that it received the first ever FDA clearance for a fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images obtained by a...

Ingenium Therapeutics, a leading innovator in next-generation NK cell therapies, announced today that its investigational therapy IGNK001 (Gengluecel) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the...

Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA). The FDA has determined the device is substantially equivalent to predicate devices...

Abbott today...

Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for...

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved HERCESSItm...

Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, for...

International medical imaging IT and Cybersecurity company Sectra's (STO: SECT B) digital pathology solution together with Leica Biosystems, Imaging, Inc.'s Aperio GT 450 DX have received a 510(k) clearance by the US Food & Drug Administration (FDA)....

Labcorp , a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCytetm Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient...

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices: "A Milestone in Facilitating the Development of Safe and Effective Biosimilars," by Sarah Yim,...

Ractigen Therapeutics, a leader in the development of small activating RNA (saRNA) therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for RAG-01, a...

Medtronic plc , a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptivtm closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv...

Provisio Medical today announced FDA 510(k) clearance of the Provisiotm SLT IVUStm System. Sonic Lumen Tomography (SLT) technology addresses a critical unmet need for vascular specialists by providing automatic, real-time, accurate, numeric...

Freedom Biosciences, Inc. ("Freedom Bio" or the "Company"), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the...

Medivir AB (STO: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease...

The Pediatric Neuro-Oncology Consortium Foundation (PNOC Foundation), a platinum rated non-profit dedicated to supporting...

Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and...

Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric (ages 12-17) and adult patientsGastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare cancer that...

Pillar Biosciences, Inc., the leader in Decision Medicinetm, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and testing costs, today announced that the U.S. Food and...

OsteoRemedies® LLC, an orthopedic company focused on providing simple solutions to complex disorders, has announced FDA clearance for expanded indications for the SPECTRUM® GV Bone Cement. The expanded indication covers the fixation of revision hip...

Innocan Pharma Corporation ("Innocan" or the "Company"), is pleased to announce that is has reached a key milestone: the Company submitted its letter of application for a Pre-IND...

Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new and exciting player in the peripheral thrombectomy market. ...

- Cochlear Limited , the global leader in implantable hearing...

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a...

X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This...

Scopio Labs, developer of Full-Field Digital Cell Morphologytm imaging and analysis platforms and a recognized leader in digital morphology, today announced that it has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for...

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based...

Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstimtm Spine Fusion...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products...

SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd., today announced the U.S. Food and Drug...

More hope for successfully combating some of the deadliest cancers. Lamassu Biotech is proud to announce its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products...

Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic...

Labcorp , a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox  PCR Test Home Collection Kit to aid in the...

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel airway clearance and ventilation solutions, is excited to announce the expanded indication granted to the BiWaze® Clear System. The...

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, the FDA authorized for marketing MMI North America, Inc.'s Symani Surgical System, indicated for use during certain...

BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027. BC2027, which is BioCity's second first-in-class antibody drug...

Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center became the first in the nation to use a novel pulsed field ablation (PFA) system to treat patients with paroxysmal and persistent atrial fibrillation,...

C2Sense, Inc., experts in advanced optical sensing platforms and Princeton BioMeditech Corporation (PBM), a world leader in rapid, point-of-care (POC) diagnostics, announced today that they have secured a second National Institutes of Health (NIH)...