News by subject: FDA

Lannett Company, Inc. today announced that it has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino®, the company's branded topical anesthetic product, at its main plant in Seymour, Indiana. The company...

Akeso, Inc. (9926. HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, announced that the Center for Drug Evaluation (CDE) of China...

Endymed Ltd , currently traded on the Tel Aviv Stock Exchange, is proud to announce that it has been granted FDA approval for the marketing and sales of Pure Laser, a new hair removal device in the United States. The Pure Laser was developed in the...

Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TELIGENtm System, an integrated technology platform...

Tris Pharma, Inc. (Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that DYANAVEL® XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL® XR (amphetamine) extended-release...

Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a...

Vitti Labs, an AATB Accredited Tissue Bank focused on life science research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) of EV-Pure, an...

Zhiyi Biotech announced that FDA has approved the Company's Investigational New Drug (IND) application to develop SK10 (Inactivated Bacteroides fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID) . The approval of this IND authorizes...

Tampa General Hospital (TGH), in partnership with Florida Urology Partners, are the first in the U.S. to offer a next-generation technology that recently received U.S. Food and Drug Administration (FDA) 510(k) clearance....

Medtronic plc today announced it has received U.S. Food and Drug Administration (FDA) approval for expanded labeling of a cardiac lead that taps into the heart's natural electrical system, giving patients needed therapy while avoiding complications...

Lucid Hearing, LLC, a Fort Worth-based market leader and global provider of advanced hearing technology and audio solutions, is offering its over-the-counter hearing aids to consumers in more than 450 Sam's Club locations nationwide starting today....

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on oncology, announced today that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand...

ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous...

The Plastic Surgery Foundation (PSF) received approval from the U.S. Food and Drug...

QT Imaging, Inc., a medical imaging company focused on the development and clinical adoption of novel products for breast cancer imaging, today announced the award of a five-year National Cancer Institute grant to study the progress of neo-adjuvant...

RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion...

BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's resubmission of the Biologics License Application (BLA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for...

Convergent Dental, Inc., the power behind the Solea® All-Tissue Dental Laser, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new, exclusive indication. Solea® is now the first and only...

Merck , known as MSD outside the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC)...

SiSaf Ltd, an RNA delivery and therapeutics company, announces that it is initiating the U.S. FDA Regulatory process to obtain an Orphan Drug Designation for SIS-101-ADO, a siRNA therapeutic for patients with Autosomal Dominant Osteopetrosis Type 2...

OsteoCentric Technologies, a privately held medical device company pioneering Mechanical Integration technology (UnifiMItm) for orthopedic and dental implants, has been issued two new FDA 510k clearances. The OsteoCentric Pedicle Screw Fastener...

CTL Amedica Corporation has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market its MONDRIAN Anterior Lumbar Interbody Fusion (ALIF) Cage System with Supplementary Fixation Plate. Designated K213641/S003, the...

Eligo Bioscience, a leading in vivo gene-editing company, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation for its oral drug candidate EB003, for the...

COPAN Diagnostics Inc. is proud to announce the second FDA clearance of Colibrítm, a semi-automated pre-analytical processor that is a complementary part of WASPLab®, COPAN's full laboratory automation system....

ZEISS Medical Technology announced that it has received 510(k) clearance from the FDA for MTLawtontm. These new disposable bipolar forceps are made from a special copper-base alloy and potentially reduce tissue adhesion and subsequent charring during...

Phagenesis Ltd, today announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Phagenyx® Neurostimulation System, a first-of-its-kind therapy that uses pharyngeal electrical stimulation to restore swallowing...

LimaCorporate proudly announces the FDA approval of a new shoulder platform focused on versatility and Operating Room efficiency. For the first time in the history of LimaCorporate, both the glenoid baseplate and the humeral stem are fully...

Today, the U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known...

Global manufacturer and distributor of high-quality airway and respiratory products, Pulmodyne, Inc., and fluidics-based MedTech company, fluidIQ, Inc., announced today a global licensing and joint research and development agreement. Pulmodyne, an...

Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), announced the submission to the U.S. Food and Drug...

Over the course of this year, AbbVie has proven successful in expanding their immunology portfolio to offset potential Humira losses with the impending launch of adalimumab biosimilars in January of 2023. Specifically, the Chicago-based manufacturer...

Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced the submission of a New Drug...

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities....

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that TST004, its...

QT Medical announces FDA clearance of PCA 500, a resting 12-lead electrocardiogram (ECG or EKG), for use in pediatric patients. First cleared in 2018 for professional and personal use by adults 18 years and older, PCA 500's new FDA clearance expands...

Olive Diagnostics, an IoMT MedTech startup that uses AI for 100% passive urine analysis, announced that it has received the CE Mark in Europe for the Olive KG, the world's first hands-free, non-invasive, AI-based optical device for 100% passive and...

Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND)...

Taiho Oncology, Inc....

Trust Garden Leader International Business Co., Ltd.'s (TGL) latest FDA approval gives the company's aseptic PET neutral and alkaline beverages the green light for import into the US. With this news, TGL is going a step beyond by also applying for...

The FDA approves AMX0035, the first new treatment for ALS in years. The new treatment was funded by donations from the Ice Bucket Challenge, the 2014 social media phenomenon that swept the globe, with 17 million participants raising $115 million for...

The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of sodium phenylbutyrate/taurursodiol (Relyvrio) for the treatment of amyotrophic lateral sclerosis (ALS), on September 29. Relyvrio will be made...

The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. "This approval provides another important...

BioMarin Pharmaceutical Inc. announced today that the Company resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with...

In an exciting development, the U.S. Senate unanimously passed the FDA Modernization Act 2.0, S.5002, a bill that was reintroduced yesterday by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., who co-sponsored the original bill (S.2952). This...

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the...

Xenocor, a Utah-based medical device company, today announced that the FDA cleared the enhanced version of their Saberscope, the world's first true HD, fog free, articulating, single-use laparoscope. The Saberscope is designed to improve patient...

Verismo Therapeutics, a clinical-stage CAR-T company and Penn spinout, and pioneer of the novel KIR-CAR platform technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SynKIR-110tm...

Point Robotics MedTech Inc. (Point Robotics), a rising star in the field of orthopedic surgery, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its minimally invasive surgical robot, POINTtm Kinguide Robotic-Assisted...

Brand Institute is proud to announce its work with Heron Therapeutics in developing the brand name APONVIEtm, which was approved by the FDA September 16, 2022....

Harrow , an eyecare pharmaceutical company exclusively focused on...