The U.S. Food and Drug Administration (FDA) granted Genentech, a member of the Roche Group, a Breakthrough Therapy Designation for its cancer immunotherapy trial MPDL3280A (anti-PDL1). Read More »

Astellas Pharma said on Monday that its clinical trial data is now accessible through ClinicalStudyDataRequest.com, an independent website that lets users access data after research proposals are approved by a review panel. Read More »

The U.S. Food and Drug Administration (FDA) approved PREZCOBIX™ (darunavir /cobicistat) tablets for the treatment of human immunodeficiency virus (HIV-1), Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced on Jan. 29. Read More »

The Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA) recently recommended approval of Sivextro (tedlizolid phosphate), an antibiotic used to treat acute bacterial and skin structure infections from Gram-positive microorganisms. Read More »

Savaysa (edoxaban) has been approved by the Food and Drug Administration to reduce the risk of stroke and blood clots in patients with atrial fibrillation not caused by a heart valve problem. Read More »

The U.S. Food and Drug Administration (FDA) recently approved the drug Natpara, manufactured by NPS Pharaceuticals, Inc., to treat low blood calcium levels in patients with hypoparathyroidism. Read More »

The U.S. Food and Drug Administration (FDA) recently approved the Maestro Rechargeable System, a unique treatment for obesity that is surgically implanted and targets the nerves between the brain and the stomach. Read More »

United States retail pharmacies now have access to Incruse Ellipta and Arnuity Ellipta, two recently approved GlaxoSmithKline (GSK) products used to treat chronic obstructive pulmonary disease (COPD) and asthma. Read More »

With the majority of seniors favoring preferred pharmacy plans as part of Medical Part D this year, the Pharmaceutical Care Management Association (PCMA) said it just goes to show eliminating the program is a bad idea. Read More »

The U.S. Food and Drug Administration (FDA) approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets (Lamictal ODT) this week, clearing the way for Impax Laboratories, Inc. to start marketing the antiepileptic drug to consumers. Read More »

A method developed by Roche Molecular Diagnostics to test nasal specimens simultaneously for methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) has received 510(k) clearance from the Food and Drug Administration, Roche said Monday. Read More »

Pharmacy benefit manager Prime Therapeutics, LLC recently agreed to place Gilead Sciences' Harvoni and AbbVie's Viekira Pak on its preferred drug list for hepatitis C patients. Read More »

A recent study by researchers at Brigham and Women’s Hospital and the CVS Health Research Institute found that improved prescription drug insurance contributes to better patient health and decreases the likelihood of patients needing more costly medical services. Read More »