News by subject: FDA

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...

The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLRtm in the treatment of occlusive disease of the superficial femoral...

Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced it has received both FDA 510(k) clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator. ECHO is an...

Olympus Corporation, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today that, for the first time in the U.S., it will demonstrate the EVIS X1tm endoscopy system, its most...

The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLRtm in the treatment of occlusive disease of the superficial femoral...

U.S. FDA Breakthrough Device designations are granted to expedite the review of technologies with the potential to greatly impact those suffering from life threatening and debilitating diseases.Cognixion ONE Axon aims to become the first FDA cleared...

Formus Labs today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Formus Hip as the first "automated radiological image processing software" for hip replacement pre-op planning. The New...

Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in...

Ricoh USA, Inc. today announced RICOH 3D for Healthcare ? a HIPAA-compliant, ISO 13485 certified 3D medical manufacturing center for the development, design and production of 3D-printed anatomic models ? has received 510(k) clearance from the U.S....

Centricity Vision Inc., a global ophthalmic technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new ZEPTOLinktm IOL Positioning System. The new platform seamlessly integrates...

Aadi Bioscience, Inc. , a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that it will host a conference...

Vanda Pharmaceuticals Inc. (Vanda) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information. Vanda alleges that the U.S. Food and Drug Administration...

Low back pain costs the US economy $100B annually. The lifetime prevalence of low back pain is reported to be as high as 84%, and the prevalence of chronic low back pain (CLBP) is about 23%, with 11-12% of the population with CLBP being disabled.A...

Full year 2022 Motion Preservation record revenue was approximately $45 million, achieving the number two total disc replacement (TDR) market position globally.Centinel Spine continues to lead the global lumbar TDR market with an estimated number one...

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today the FDA clearance of the new EVIS X1 endoscopy system, along with two compatible gastrointestinal endoscopes:...

NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for...

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy...

Apyx Medical Corporation , the manufacturer of the proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for...

Today, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Nonregenerative anemia can...

Medtronic plc , a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micratm AV2 and Micratm VR2, the next generation of its industry-leading miniaturized, leadless...

The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries....

Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of...

Padagis today announced the launch of Budesonide 2mg Rectal Foam (generic to Uceris®) with 180-days of Competitive Generic Therapy exclusivity....

OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and...