Abyrx, a US-based therapeutic device company, has received the US Food and Drug Administration (FDA) approval for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use. AHBP is a surgical ready-to-use product which achieves ...
Tags: Abyrx, Bone Putty
LED Medical Diagnostics, a developer of tissue fluorescence visualization technologies, has announced that its patented VELscope Vx oral examination device is presently involved in a Phase III study, which is sponsored by the University of ...
Tags: Oral Cancer Study, Medicine
Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won't approve their devices for use, the FDA said. The FDA issued new ...
Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
St. Jude Medical, a medical device manufacturer, has received US Food and Drug Administration (FDA) approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac ...
Tags: St.Jude, SJM Assura Devices
Cumberland Pharmaceuticals has received the US Food and Drug Administration’s (FDA’s) approval for updated labeling of Acetadote (acetylcysteine) Injection, which is free from Ethylene diamine tetracetic acid (EDTA) or any other ...
Tags: Cumberland, Labeling of Acetadote
France-based specialty diagnostic solutions provider Diaxonhit and XDx in the US, have entered into a memorandum of agreement (MoU) for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap) in Europe. ...
Tags: Diaxonhit Partners, Market Allomap
The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy. Following to completion of review of the Trokendi ...
Tags: Supernus Trokendi, FDA Approval
Stemline Therapeutics' SL-401 has won orphan drug designation from the Food and Drug Administration (FDA) for the treatment of aggressive hematologic malignancy blastic plasmacytoid dendritic cell neoplasm (BPDCN). With an orphan drug ...
Tags: Stemline Therapeutic, Orphan Drug
Eisai has announced the availability of Belviq (lorcaserin HCl) CIV tablets in the US, which is designed for chronic weight management in adults who are overweight with a comorbidity or obesity. Indicated for people with body mass ...
Tags: Eisai, Weight Management Therapy
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
The US FDA has cleared Sanofi Pasteur's supplemental biologics license application (sBLA) licensing four-strain influenza vaccine, Fluzone Quadrivalent, for broad age range of children and adults. As the first and only four-strain ...
Tags: Influenza Vaccine, Medicine
US-based Cumberland Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for updated labeling for Acetadote (acetylcysteine) Injection. According to the company, the new labeling revises the indication of ...
Julian’s Recipe is voluntarily recalling European Style Pretzel Baguette packages from HEB Stores in Texas, US, over allergy concerns. According to the company, certain packages of Pretzel Baguettes may contain Julian's European ...
Respitek, a South Africa-based disposable medical devices maker, has received the US Food and Administration (FDA) clearance for the Bobbi Baby Shield, which is meant to shield against infection post Hypospadias repair surgery. Meant for ...
Tags: Respitek, Bobbi Baby Shield