News by subject: FDA

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...

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announces that the US Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for leniolisib, an oral,...

Shanghai Fosun Pharma (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH; 02196.HK) today announced that the 20 ml, Sodium Phenylacetate and Sodium Benzoate (SPSB) liquid product, which is under an exclusive partnership between Fosun Pharma USA...

Pain Specialists of America (PSA) announced it is integrating the new Proclaimtm Plus spinal cord stimulation (SCS) system featuring FlexBurst360tm therapy for patients receiving neuromodulation therapy for chronic pain. Recently approved by the U.S....

Oncopeptides AB (publ) (Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug...

DyAnsys, Inc., has announced that Primary Relief, a percutaneous electrical neurostimulation device, has been approved to treat pain following a cardiac surgery....

The U.S. Food and Drug Administration (FDA) has granted QT Imaging, Inc. 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV). This ratio can contribute to an assessment of risk...

Keymed Biosciences (HKEX:02162) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted CMG901 the Breakthrough Therapy Designation for the treatment of advanced gastric and...

Keymed Biosciences (HKEX:02162) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted CMG901 the Breakthrough Therapy Designation for the treatment of advanced gastric and...

Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has granted approval to Retevmo® (selpercatinib, 40 mg...

Bracco Diagnostics Inc., the...

Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, and the first to bring a macrocyclic GBCA to the global market, is proud to announce...

- FDA approval of Eluciremtm (NDA 216986) was granted after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious...

Biocodex, Inc., a pharmaceutical company and manufacturer of DIACOMIT® (stiripentol), announced today that the U.S. Food and Drug Administration (FDA) has approved DIACOMIT for the treatment of seizures associated with Dravet syndrome in patients 6...

Charsire Biotechnology Corp. has successfully developed a revolutionary new drug (BAC) for Alzheimer's disease and vascular dementia using its patented technology of Multi-Glycan Complex and soybeans as raw materials. BAC has completed Phase II...

Immunitas Therapeutics ("Immunitas"), a precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced that the U.S. Food and Drug Administration...

Stryker , one of the world's leading medical technology companies, announced today that its OptaBlate bone tumor ablation system (OptaBlate) received 510(k) clearance from the U.S. Food and Drug Administration. The addition of the OptaBlate...

Medtronic plc , a global leader in healthcare technology, today announced the LINQ IItm Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric...

Verismo Therapeutics, a clinical-stage biotechnology company and a Penn-spinout behind the novel KIR-CAR platform technology, today announced that is has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug...

Alterity Therapeutics ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the approval of its Investigational New Drug (IND) application by the...

Zimmer Biomet Holdings, Inc. , a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Identitytm Shoulder System for anatomic, reverse and revision shoulder replacement. The Identity...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...