Botox approved for upper limb spasticity in children
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.
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INTEGRATED ENDOSCOPY Receives FDA Clearance for NUVIS Single-Use, HD, Battery Operated Arthroscope
Breakthrough Single-Use Endoscope Technology Approved for Arthroscopic Surgical Procedures
VIVO System cleared by FDA
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.
Promising cancer treatment awaits approval
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.
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NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone
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.
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MOLECULIN BIOTECH, INC.: Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation
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).
24 medical devices OK’d by FDA so far this year
Twenty-four medical devices have been approved as of June 18 for prescribed uses, according to the federal Food and Drug Administration.
RESEARCH AND MARKETS: Venclexta (venetoclax; AbbVie/Roche) Drug Overview & Product Profile 2017-2026: A Novel B-Cell Lymphoma 2 (BCL-2) Inhibitor that Received an Accelerated US FDA Approval
The "Venclexta" report has been added to ResearchAndMarkets.com
KOIOS MEDICAL: FDA Clears Koios DS™ Breast 2.0 to Assist Physicians with AI-Based Software
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.
ANATOMAGE: Releases Anatomage Cloud Platform Featuring One-Click Review to Provide HIPAA Compliant, FDA Approved Free DICOM Sharing and Medical Image Viewing
Anatomage Inc., a market leader in 3D medical imaging technology, released an update to the Anatomage Cloud platform that allows medical and dental professionals to quickly send 3D DICOM volumetric data to colleagues for one-click review.
ICOTEC MEDICAL: icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System
icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures.
Drug companies want clarity on FDA guidelines for bispecific antibodies
A group of major pharmaceutical companies is asking the US Food and Drug Administration to consider changes to the agency's guidelines on developing bispecific antibodies.
Flaws in the system allow Clinicaltrials.gov to host illegal trails
The website Clinicaltrials.gov is home to a broad spectrum of clinical trials, both legitimate and illegal, according to FDAMap.com.
GRIFOLS: Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies
Xembify® is Grifols' first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies
FDA OK'd 227 drugs in June
The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.
PREMIER INC.: Premier’s ProvideGx™ Program to Make the First FDA-Approved Version of Cysteine Hydrochloride Available to Providers
Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.
LUMINEX CORPORATION: Luminex Submits ARIES MRSA Assay for FDA Clearance
Luminex Corporation (NASDAQ: LMNX) announced that the company submitted the ARIES® MRSA Assay to the U.S. Food and Drug Administration (FDA) for clearance on Friday, June 28, 2019.