News by subject: FDA

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology...

Laser & Cosmetic Surgery Specialists, the renowned cosmetic clinic headed by Dr. Ran Y. Rubinstein, is thrilled to announce the introduction of SKINVIVEtm by JUVÉDERM®, a groundbreaking development in aesthetic medicine. As of this month, SKINVIVEtm...

Indivior PLC (LSE: INDV) today announced that...

Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first...

Hanx Biopharmaceuticals, Inc. (HanxBio), announced that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in...

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab)....

Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Orlucent® Skin Fluorescence Imaging System....

Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular...

Features FDA 510(k) cleared High Impact Denture Base resin, the first ceramic-infused 3D printing material for denture bases, and certified biocompatible High Impact Denture Teeth resinLeverages proprietary, future-forward NanoFusiontm technology...

cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, Lincoln, Nebraska-based Virtual Incision Corporation, has...

Laekna, a clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND)...

Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with...

AbbVie today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R)...

Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated...

Abbott today announced that the...

Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, recently received Phase 1/2a IND approval from the U.S FDA on May 6th for its Glioblastoma Multiforme (GBM) treatment called...

?  The co-primary endpoints of endoscopic response (visible reduction of intestinal lining damage) and clinical remission were achieved by significantly more patients treated with RINVOQ (upadacitinib) at week 12 and week 52 versus placebo1? ...

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Neurophet, an artificial intelligence (AI) solution company for brain disease, announced that the US Food and Drug Administration (FDA) 510(k) has cleared "Neurophet AQUA"....

Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell?based protein expression system, today...

Lumen Bioscience?a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases?today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for LMN-201, an investigational,...

Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. The trial will assess the safety and...

Ketryx, the creator of the first connected lifecycle management software for MedTechs, today announced new usability and productivity updates to its flagship software. Recent guidance from the FDA on cybersecurity, AI/ML, and increasing connectivity...

Perrigo Company plc , a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for Nicotine Coated Mint Lozenges, 2 mg and 4 mg over-the-counter ....

FDA approval was backed by Abbott's DISTINCT study, the largest randomized controlled trial for spinal cord stimulation (SCS) in people with chronic back pain when surgery is not an optionResults for the first 200 patients demonstrated that people...

OncoSec Medical Incorporated (the Company or OncoSec), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient's immune system to target cancer cells and eradicate disease, today announced a Type C...

Phio Pharmaceuticals Corp. , a clinical stage biotechnology company whose proprietary INTASYLtm RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that the U.S. Food and Drug...

Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. The trial will assess the safety and...

Byondis B.V., an independent, Dutch clinical-stage biopharmaceutical company creating precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License...

MIM Software Inc., a leading global provider of medical imaging software, announced US Food and Drug Administration (FDA) clearance of its newest version of the AI auto-contouring solution Contour ProtégéAI....

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor...

Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor...

Novarad's VisAR, a surgical navigation system that uses augmented reality, has received clearance from Indonesia's FDA for intraoperative use in stereotactic spinal surgery. VisAR is accurate for both open and minimally invasive surgery (MISS). This...

Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer's disease. This is the first FDA-approved treatment...

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 United States (U.S.) Food and...

Perrigo Company plc , a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory...

OpSens Inc. ("OpSens" or the "Company")  , a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, is pleased to announce SavvyWire inclusion in the COMPLETE TAVR clinical study to...

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the...

Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ampreloxetine for the treatment of symptomatic neurogenic...

Following last years infant formula crisis, food safety attorney, Bill Marler, of Marler Clark, Inc., PS, The Food Safety Law Firm, launched the "GET THE F OUT OF THE FDA" campaign. ...

Hubly Surgical announced today that they received 510k clearance from the FDA to market the Hubly Drill, an innovative medical technology developed with the goal of making burr hole procedures safer and more efficient in any setting, including...

National Surgical Centers Stockton (NSC Stockton), an outpatient surgery center, is now offering high-frequency spinal cord stimulation (SCS) procedure(s) for the treatment of painful diabetic neuropathy (PDN). The technology, called HFX, is made by...

Omeq Medical Ltd. a portfolio company of The Trendlines Group Ltd. (SGX: 42T) , announced today that it has received regulatory clearance from the United States Food and Drug Administration ("FDA") for its EpiFinder, which assists physicians to...

AbbVie , today announced that Health Canada...

New Talicia PBPK modeling data, published in AP&T Journal, showed that generically substituted regimens are non-bioequivalent to Talicia Separately, new Talicia PBPK modeling data, presented at DDW, supports bioequivalence between TID and Q8H dosing...

According to Prophecy Market Insights "Generic Sterile Injectables Market accounted for US$ 68.7 billion in 2019 and is estimated to be US$ 196.2 billion by 2029 and is anticipated to register a CAGR of 11.2%" What is the Overview of Generic Sterile...

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,...

Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, today announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch...

HAPPE Spine, a medical device company focused on bringing innovative materials to orthopaedic implants, announces that the company's INTEGRATE-Ctm Interbody Fusion System has received 510k clearance from the FDA....

Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA.   GEN6050 is an in vivo base editing drug that targets exon 50 skipping in the Duchenne...