News by subject: FDA

Harmony Biosciences Holdings, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS)....

WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for...

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to...

Today, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the...

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew...

Curadev is excited to introduce CRD3874, a first-in-class allosteric small molecule STING agonist, with distinct pharmacological properties that distinguish it from agents that bind to STING's cGAMP site. An intravenous formulation of this lead asset...

Caliway Biopharmaceuticals (Caliway) announced that the...

SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments to address the global myopia epidemic, today announced that the U.S. Food and Drug Administration (FDA) has...

Numinus Wellness Inc. ("Numinus" or the "Company") , a mental health care company advancing traditional and innovative behavioral health...

Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. "This approval provides patients with the first-ever treatment option for severe...

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 other indications, today announced a shareholder update with a projected...

Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced that the United States Food & Drug Administration (FDA) has granted its novel Efemoral Vascular Scaffold System (EVSS) Breakthrough Device status for the...

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that it has received clearance from the US Food and Drug...

QT Medical, a medtech company focusing on improving cardiac care with electrocardiogram (ECG or EKG), announces that it has received 510(k) clearance from the FDA for PCA 500tm use in acute care. PCA 500 was first 510(k) cleared in 2018 for...

Pioneering a new approach to treat depression, NeuroQore, Inc. ? a neurotechnology company supported by the Ontario Brain Institute and SOSV ? has received U.S. Food and Drug Administration 510(k) clearance for its groundbreaking neuromodulation...

Edgepark announced today it is offering the newly launched Beta Bionics iLet Bionic Pancreas fully automated insulin delivery (AID) system as part of its comprehensive diabetes management solution portfolio. The iLet is the first and only system that...

Phase 2 trial, expected to begin in 1H 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with associated acute hypoxemic respiratory failure, a condition associated with a high mortality rate...

Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia...

CymaBay Therapeutics, Inc. , a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA)...

Proscia®, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq® AP-Dx*. The digital pathology solution was cleared for...

Dr. George Waring IV of The Waring Vision Institute (Mt. Pleasant, SC ) will be the first in the nation to perform patient treatments on the just approved TENEOtm Excimer Laser Platform for Myopia and Myopic Astigmatism. "The precise engineering of...

CH4 Global today issued the following statement regarding the announcement by the U.S. Food and Drug Administration (FDA) that it plans to withdraw a policy that caused multi-year approval delays for certain animal-feed additives that can produce...

Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.This will enable Fresenius Medical Care to offer the industry-leading, high-volume hemodiafiltration (Hv-HDF)...

Ionis Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid...

Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S. Food and Drug Administration (FDA). The ANNE® One platform now allows for...

SmartCella, through its business unit ProCella, has been approved by the Swedish Medicinal Product Agency for manufacturing and quality control testing of sterile biological medicinal products for cell therapy. SmartCella is pleased to announce that...

Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio...

Zynex, Inc. , an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that it has received clearance from the U.S....

StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs' position at its...

Vanda Pharmaceuticals Inc. (Vanda) today announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA)...

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US....

Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (??2) T cell platforms to address gaps in cancer care, today announced...

Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of...

Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their...

NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug...

Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular...

By combining years of clinical experience with cutting-edge research and development, IlluminOss Medical announces it has received FDA 510(k) clearance for a new Light-Emitting Diode (LED) Console to speed curing of its patented, light-cured...

Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis....

As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced recent FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable...

Labcorp , a global leader of innovative and comprehensive laboratory services, today announced the launch and availability of a new, FDA-cleared blood test for risk...

Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSEtm Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the...

Kemin Industries, a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services, conducted extensive research that served as the basis for the U.S. Food...

Bot Image, Inc., a Nebraska and Maine based Artificial Intelligence medical device company (www.botimageai.com), raised the performance bar with its FDA-cleared AI software ProstatIDtm. The unique trifecta clearance of this software used for prostate...

IceCure Medical Ltd. ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug...

NeoImmuneTech, Inc....

Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrítm. The automated ID/AST preparation instrument is a key component in Copan's full...

Vanda Pharmaceuticals Inc. (Vanda) today announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for...

Halozyme Therapeutics, Inc. ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy...

Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food...

Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for a line extension to the...