News by subject: FDA

BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company...

HEMGENIX® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years post-treatmentLong-term data continues to show a one-time...

Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion...

Inspira Technologies OXY B.H.N. Ltd.  (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, is pleased to announce the appointment of Dr. Dan Gorfil to its medical advisory...

Celltrion USA today...

cultivate(MD), a leader in medical device venture capital, is thrilled to announce that one of its portfolio companies, NSite Medical, has received FDA clearance for its groundbreaking AI-based scoliosis scanning application. This marks a significant...

Boston Medical Center (BMC), a national leader in the treatment of sickle cell disease for more than 50 years, announced today that it will offer the first-ever gene therapy treatment program for sickle cell disease that uses a type of novel genome...

Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved CRESEMBA® (isavuconazonium sulfate), an azole antifungal drug, for...

Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of...

Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration...

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 system, which provides fast,...

BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has received 510(k) clearances from the U.S. Federal Drug Administration (FDA) for a novel blood collection device that obtains blood samples from a...

Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI). The kit was created to...

Bering Limited, a London-based medical AI company, today announced it received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest X-Ray triage solution, 'BraveCX'. With the FDA clearance, the company is now able to...

Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of peritoneal to provide therapy for malignant ascites in addition to recurrent pleural effusions....

NSite Medical, a leader in scoliosis care and treatment, is excited to announce the FDA clearance of its innovative AI-based Scoliosis Assessment Application. This technological breakthrough signifies a major advancement in scoliosis diagnosis and...

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and...

Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients1-5 In APPLY-PNH, patients who switched to Fabhalta experienced superior...

SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1,...

Company Today Also Provided Updates on R&D Portfolio and Strategy at Investor Event Crinecerfont New Drug Application Submission Planned in 2024NBI-'770, an Oral NMDA NR2B Negative Allosteric Modulator, Entering Phase 2 for the Treatment of Major...

ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device...

Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label...

Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis....

Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk...

West Pharmaceutical Services, Inc. , a global leader in innovative solutions for injectable drug administration systems, today announced FDA 510(k) clearance and launch of its Vial2Bag Advanced® 13mm admixture device....

Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for LITFULOtm (ritlecitinib). A once-daily oral treatment, LITFULO is the first and only treatment approved by Health Canada for individuals 12 years of age...

Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib,...

Alafair Biosciences announced today that VersaWrap has received 510(k) clearance from the FDA, enabling application of VersaWrap in all populations, regardless of age. The additional clearance allows pediatric surgeons and facilities the flexibility...

Transit Scientific, a Utah-based medical device company specializing in innovative solutions for vascular procedures, has announced the FDA clearance of its microcatheter designed for the precise delivery of a broad range of embolic agents. This...

Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)?two related blood diseases that disproportionally strike older adults?are notoriously difficult to treat and associated with high relapse rates. Although new therapies have improved...

Accorto Regulatory Solutions, LLC. (Accorto), a US-based regulatory firm specializing in helping small to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated products to market, and Inter Scientific Ltd., an...

Carisma Therapeutics Inc. ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the clearance of its Investigational New Drug application (IND) by...

Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's lead product, the TriVeritytm Acute Infection and Sepsis Test...

Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with...

Neurelis, Inc., a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, announced that it has secured the issuance...

BrainSpec, the comprehensive software platform enabling virtual biopsies of the brain, has been awarded clearance by the...

AWAK Technologies (AWAK), a pioneering medical technology company developing a wearable dialysis product and other complementary solutions for chronic kidney disease (CKD) management, today announced that its kidney disease progression prediction...

RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness...

Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted...

The "FDA Inspections and Audit Readiness Course" training has been added to  ResearchAndMarkets.com's offering. This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what,...

4DMedical, the leading producer of advanced lung function imaging software has received FDA clearance for its CT-based ventilation product (CT LVAStm). CT LVAS, designed for use with computed tomography...

Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine. Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in...

Brainomix, the AI-powered medtech solutions company, has heralded its continued US expansion with the launch of its full suite of FDA-cleared modules in its...

Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine. Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in...

Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from...

MIRA Pharmaceuticals, Inc. ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company, today revealed groundbreaking insights into the cognitively enhancing effects of MIRA1a in normal mice during a presentation at the...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that U.S. Food and Drug Administration has approved its Phase II IND...

Pixyl has announced FDA 510(k) clearance for Pixyl.Neurotm, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%1. Pixyl is an award-winning French medtech specializing in AI-powered...

NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration...

Medtronic plc , a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyraltm renal denervation (RDN) system, also known as...