News by subject: FDA

TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") , a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, announced today that it has successfully registered...

Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in blood...

Helix, a nationwide leader in population genomics, COVID-19 diagnostic testing and viral surveillance, has received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit for use in a secure 'Locker...

PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is proud to announce that their PDO device continues to comply with The Medical Device Single Audit Program ?...

Ariste Medical, a pre-commercial drug+device company, today announced it has received 510(k) clearance (#K211132) from the U.S. Food and Drug Administration (FDA) to market its drug-embedded, synthetic hernia mesh in the United States. The new mesh...

Abbott's Aveir single chamber (VR) pacing system is the world's only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placementAveir VR has an increased projected battery life that can be up to two times...

Precigen, Inc....

Nobelpharma America, LLC, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, and a subsidiary of Nobelpharma Co., Ltd. in Tokyo, today announced that the U.S. Food and Drug Administration (FDA) has approved HYFTORtm...

Today the TSC Alliance® applauds the U.S. Food and Drug Administration's (FDA's) approval of HYFTORtm, which is the first FDA-approved topical treatment for facial angiofibromas in adults and children six years of age or older who have tuberous...

Radiaction Medical Ltd. ("Radiaction"), an innovative medical device company focused on radiation protection in the interventional cardiology and electrophysiology sectors, announced FDA 510(K) clearance for the marketing of its Shield System in the...

Regeneron Pharmaceuticals, Inc. and Sanofi today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority...

Radiaction Medical Ltd. ("Radiaction"), an innovative medical device company focused on radiation protection in the interventional cardiology and electrophysiology sectors, announced FDA 510(K) clearance for the marketing of its Shield System in the...

Edwards Lifesciences today announced it received approval from the U.S. Food and Drug Administration (FDA) for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position. The MITRIS RESILIA valve has a...

Aidoc, the leading provider of healthcare AI solutions, today announced that it received FDA 510(k) clearance for its triage and notification of pneumothorax on X-ray exams. A one-stop partner for the enterprise's clinical AI needs, Aidoc's other...

Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously...

CartiHeal Ltd, developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its...

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA...

Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently...

Cellmyx, the authority on autologous adipose grafting and transfer, and a leader in medical technologies for orthopedic physicians, pain management and regenerative medicine, announces U.S. Food and Drug Administration (FDA) 510(k) clearance for...

Lipocine Inc. , a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares Pharma, Inc. issued a press release announcing that the U.S. Food and Drug...

Telix Pharmaceuticals Limited  today announces that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for TLX66 (90Y-besilesomab), for conditioning treatment prior to hematopoietic stem cell transplant...

Envista Holdings Corporation ("Envista") -- Envista announced today the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing feature in its image acquisition and diagnostic software platform...

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2 mg dose of Ozempic® (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood...

Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring device have received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug...

Immorna Biotherapeutics, Inc. (Immorna), a rapidly-expanding biotechnology company developing both self-replicating and conventional mRNA-based therapeutics and vaccines, announced today that the U.S. Food and Drug Administration (FDA) has cleared...

FINTEPLA® has demonstrated efficacy in the most difficult-to-treat seizure types,1,2 including drop seizures, which cause a person to suddenly lose muscle tone, become limp, and fall to the ground, with a high likelihood of injury3LGS is a severe...

Sky Medical Technology Ltd (Sky) has today announced it has achieved further U.S. Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) gekotm device variant, for increasing microcirculatory blood flow in lower limb soft tissue...

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for CABENUVA (cabotegravir and rilpivirine), giving healthcare professionals and people living with...

HLT Inc., a Bracco Group Company and a leader in the development of cutting edge transcatheter aortic valve replacement (TAVR) therapy, announced today that it has received U.S. Food and Drug Administration (FDA) approval for two clinical studies to...

FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions2Metastatic prostate cancer has a 5-year survival rate of less than 30%3; mCRPC patients who...

Today, Aimed Alliance, the Center for U.S. Policy and the International Health Facility Diversion Association commended the federal government for facilitating patient access to prescription digital behavioral therapies. The Centers for Medicare &...

TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510(k) clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA...

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announced its 2021 Annual Results. Business Highlights CT053: completed...

TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") , a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, announced that it has received MHRA and Research...

Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 027 micro-catheters, available in two lengths, expanding its...

Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has submitted a regulatory filing for the next clinical Phase 3 study for MOB-015 (nail fungus treatment) to the...

Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, today announced it received US Food and Drug Administration (FDA) clearance for its Solus...

The BLA (Biologics License Application) for the "HPC-Cord Blood" product, was submitted to FDA on January 7th, 2022, and StemCyte was officially notified on March 8th, 2022, that the submission was acceptable to enter the biologics license quality...

Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in immuno-oncology announced today that it has received clearance from the US Food and Drug Administration to commence Phase I studies...

PHASE Scientific International, LTD (PHASE Scientific), a high-growth biotech company founded by bioengineers from UCLA, announces that its INDICAID® COVID-19 Rapid Antigen At-Home Test (INDICAID® OTC) received Emergency Use Authorization (EUA) from...

Padagis today announced the FDA approval and launch of an AB-rated generic version of Tobradex® Ophthalmic Suspension. Tobradex®...

NeuroSense Therapeutics Ltd. ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pharmacokinetic study...

Provention Bio, Inc. (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the resubmitted Biologics License Application (BLA) for teplizumab for the delay of clinical...

Perrigo Company plc , a leading provider of Quality, Affordable Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for the over-the-counter use of Nasonex® 24HR Allergy (mometasone...

TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") , a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, announces orphan drug status has been granted for lead...

Bay Area Health Trust has today announced its receipt of a Health Canada Interim Order (IO) authorization for its McMaster Molecular Medium (MMM). A temperature-stable molecular transport medium, MMM inactivates and stabilizes COVID-19 specimens from...

In clinical trials, RINVOQ (upadacitinib) achieved the primary endpoints of clinical remission (per modified Mayo Score [mMS]) at weeks 8 and 521-4 A greater proportion of RINVOQ-treated patients achieved clinical response (per partial mMS [pmMS]) as...

Viatris Inc.  and Kindeva Drug Delivery L.P. today announced that, Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Breynatm...

Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age...