GlaxoSmithKline has received approval from the UK’s National Institute for Health and Clinical Excellence (NICE), for its platelet-boosting drug Revolade in the treatment of adult bleeding disorder, chronic immune (idiopathic) ...
Tags: Blood Disorder Treatment, Medicine
US-based drug store chain Walgreens has agreed to reimburse a monetary penalty of $80m to the US Drug Enforcement Administration (DEA) to settle the charges of violating federal regulations governing the distribution of prescription ...
Tags: Walgreens, Illegal Prescription
Cordis Corporation, a part of the Johnson & Johnson Family of Companies, has received approval from the US Food and Drug Administration (FDA) for its Adroit 6F Guiding Catheter. Enabling the production of a guide catheter with the largest ...
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
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 ...
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
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
The European Medicines Agency has cleared Roche's RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above. Approved for use alone or in combination ...
Tags: Arthritis Drug, Medicine
The Indian Institute of Technology (IIT) Delhi is considering establishing a pharmaceutical technology centre to improve scientific and technical education and research in healthcare and pharmaceutical. Expected to be set up within a ...
AstraZeneca has agreed to purchase California-based respiratory medication developer, Pearl Therapeutics, in a deal with a total potential cost of up to $1.15bn. As per the definitive agreement signed between both the parties, AstraZeneca ...
Tags: AstraZeneca, Pearl Therapeutics
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
Drug maker BioSyent Pharma has launched its new oral iron supplement, known as FeraMAX Powder, in Canada, which will also mark its international induction. Commenting on the introduction, BioSyent president and CEO René Goehrum ...
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