Koios Medical, Inc has received 510(k) clearance from the U.S. Food and Drug Administration for Koios DS (Decision Support) Breast 2.0, a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer.
The "Venclexta" report has been added to ResearchAndMarkets.com
Twenty-four medical devices have been approved as of June 18 for prescribed uses, according to the federal Food and Drug Administration.
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Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has filed new patents covering the production and reconstitution of Annamycin, which is currently in two clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML).
The NIHC is pleased to announce Lowell Schiller as a keynote speaker at the National Industrial Hemp Council's 2019 Business Summit.
With the majority of 510(k) submissions having major deficiencies or being rejected the first time, scientific and regulatory experts TSG Consulting recommend that manufacturers schedule a Pre-Submission (Pre-Sub) meeting with the FDA to improve the likelihood of the medical device being approved for sale in the US market.
Former Food and Drug Administration Commissioner Scott Gottlieb joined pharmaceutical corporation Pfizer’s board of directors on June 27, after stepping down from the FDA in April.
Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that the Food and Drug Administration ("FDA") has provided guidance to the Company following its Sprint Discussion on June 26, 2019, together with the Company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer™ (the "Reducer"), to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need.
Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.
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MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals' product Zytiga©, on July 9th.
New cancer treatments known as chimeric antigen receptor (CAR) T cell therapy are awaiting approval from the Centers for Medicare and Medicated Services (CMS) to be financially covered for outpatients in cancer centers or clinics.
Center for Veterinary Medicine to apply GastroPlus® to assess product bioequivalence in canines
FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months
The VIVO (View Into Ventricular Onset) system from Catheter Precision has been cleared by the Food and Drug Administration for market release in the U.S.
User Fee Goal Date is December 27, 2019
Breakthrough Single-Use Endoscope Technology Approved for Arthroscopic Surgical Procedures
Civica Rx partnership helps ensure essential, affordable, accessible generic medicines
The Food and Drug Administration approved drug company Allergan’s supplemental biologics application for Botox for patients 2-17 years old with upper limb spasticity.
Q'Apel Medical announced that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC).