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
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
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
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 ...
Cook Medical has received the 510(k) approval from the US Food and Drug Administration (FDA) for its Evolution Biliary Controlled-Release Uncovered Stent. Adding to the Cook's line of Evolution controlled-release stents for the ...
Tags: Cook Medical, Biliary Stent
Blue Belt, next generation surgical orthopedic instruments developer, has received 510(k) approval from the US Food and Drug Administration (FDA) to market its Stride Unicondylar Knee implant system. With the clearance, the Stride implant ...
Tags: Blue Belt, FDA Approval
Specialty pharmaceutical company Sun Pharmaceutical Industries has obtained final USFDA approval for the abbreviated new drug application of generic Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100mg/ml and 200mg/ml. ...
Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon ...
Tags: Angioplasty Balloon, Medicine
Traumatic injury medical devices developer iTraumaCare has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its iTClamp Hemorrhage Control System. iTClamp is designed to control severe bleeding, in seconds, and ...
Tags: Itraumacare, FDA Approval
Aurobindo Pharma has gained final FDA approval for its generic Nevirapine tablets and oral suspension used for treating human immunodeficiency virus (HIV). The FDA approved Nevirapine tablets of 200mg strength and Nevirapine oral ...
Tags: Aurobindo Pharma, FDA, Nevirapine, HIV drug
Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib). The tablets are used for the initial treatment of people with metastatic non-small cell lung ...
Tags: FDA, Tarceva Tablets, Astellas Pharma
Canada-based pharmaceutical company Nuvo Research has received US Patent relating to compositions and methods of using WF10 and new derivative formulations for the treatment of allergic asthma, allergic rhinitis and atopic dermatitis. ...
Tags: Nuvo Research, Drug Candidate
Janssen Biotech has announced the FDA approval of Simponi (golimumab) to treat moderately to severely active ulcerative colitis (UC) in adult patients with corticosteroid dependence or an inadequate response to or failed to tolerate oral ...
Tags: FDA, Janssen Biotech