News by subject: FDA

The Melanoma Research Alliance (MRA) released the following statements from MRA Chief Science Officer Joan Levy, PhD and MRA Chief Executive Officer Marc Hurlbert, PhD on the Food & Drug Administration approval of Hepzato Kit for patients with uveal...

CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA clearance and commercial availability of the PVI AnalyzerTM and Signal...

Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational...

OnCusp Therapeutics, a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, announced today the clearance of its Investigational New Drug (IND)...

ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S....

Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA). The inspection, carried out by the FDA Consumer Safety Officer, Mrs....

Delcath Systems, Inc. , an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food...

Boehringer Ingelheim announced today that SENVELGO® (velagliflozin oral solution), a revolutionary new treatment for cats with...

DRI Healthcare Trust  (the "Trust"), a global leader in providing financing to advance innovation in the life sciences industry, has...

The Janssen Pharmaceutical...

Zumutor Biologics Inc "Zumutor", a Boston based biopharmaceutical company focused on developing unique novel therapeutics in immuno-oncology (I-O) today announces that the US Food and Drug Administration (FDA) has granted the company's...

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai's Heart Monitor, a device for the non-invasive estimation of diastolic...

Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for CRESEMBA® (isavuconazonium sulfate), a prodrug of...

Genprex, Inc. ("Genprex" or the "Company") , a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the United States Food and Drug Administration (FDA) has granted...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TALVEYtm (talquetamab-tgvs), a first-in-class bispecific antibody for the...

Accuray Incorporated announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration...

Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness...

?   FDA confirmed that the ongoing Phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a BLA ?  ?   FDA agreed on the required efficacy and safety endpoints...

Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARxtm Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation...

PENTAX Medical America Inc., a division of HOYA Group, has obtained US FDA 510(k) clearance for two of its latest innovations: the PENTAX Medical INSPIRAtm, a premier 4K video processor, and the i20c video endoscope series. Developed with a focus on...

Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, enabling the company to proceed with a clinical trial for ANPD001, a personalized (autologous) cell...

Filament Health Corp.  (NEO: FH) ("Filament" or the "Company"), a clinical?stage natural psychedelic drug development company, today announced approval from the United States Food and Drug Administration (FDA) for two clinical trials at leading...

BrainStorm Cell Therapeutics Inc. , a leading developer of cellular therapies for neurodegenerative diseases, announced today that it will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2023,...

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 Compliance,...

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

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 BC3448 (CD3/EGFR Bispecific antibody, BsAb). As a result, BioCity Biopharma...

Recently, Venus Medtech (Hangzhou) Inc. ("Venus Medtech"), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the...

Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also...

Arexvy (respiratory syncytial...

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced that several...

Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis...

Today, Movano Health , a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, announced that it has submitted a 510(k) premarket notification to the U.S. Food and...

Ceribell, Inc.® today announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior...

Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as...

ABM Therapeutics (ABM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with...

Inimmune Corporation ("Inimmune"), a clinical-stage company focused on the development of innovative immunotherapeutics, today announced that the first subject has been dosed in Inimmune's phase 1/1b First-in-Human clinical trial of INI-2004,...

In the face of the ongoing supply issues affecting Intra-Abdominal Pressure (IAP) transducer kits, Sentinel Medical Technologies is stepping up to ensure that patient care remains uncompromised. The company's FDA-cleared product, TraumaGuard, is now...

Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney and bladder cancer, today announced that the U.S. Food and Drug Administration...

Genesis MedTech, a leading medical device company, today announced that its J-Valvetm Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This innovative heart valve has been...

Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System, the first whole blood automation device available in the U.S. that processes whole...

Sirius Medical, a leader in value-based healthcare and surgical marker navigation received 510(k) clearance early in 2023 for their Sirius Pintuition® Probe, used during surgery, to be resterilized by users in STERRAD NX and NX100 systems....

Tyra Biosciences, Inc. , a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today announced that the U.S. Food and Drug...

MediPharm announces first delivery of pharmaceutical cannabis product for NIH funded clinical trial, following import permit from the US Drug Enforcement Agency (DEA) and Health Canada export permit.MediPharm has provided a full response to the US...

BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAXtm System, a single molecular diagnostic...

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...

Imeka, the leading neuroimaging company combining diffusion imaging and AI to map white matter microstructure, today announced that the U.S. Food and Drug Administration (FDA) has granted...

MAGENTIQ-EYE LTD., an Israeli-based technology company founded in 2014, announced today that the U.S. Food and Drug Administration (FDA) has cleared the MAGENTIQ-COLOtm via the 510(k) process. The device, which offers the gastroenterology community...

SEKISUI Diagnostics announces the launch of the OSOM COVID-19 Antigen Home Test to diagnose COVID-19 at home.  The OSOM COVID-19...

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...