The U.S. Food and Drug Administration (FDA) on Tuesday approved Coagadex for hereditary Factor X (10) deficiency. Read More »

American Society of Health-System Pharmacists (ASHP) on Wednesday announced that there are now 2,000 residency programs across the country currently undergoing the ASHP accreditation process. Read More »

The American Society of Health-System Pharmacists (ASHP) said Friday it is disappointed with the recent decision of the U.S District Court for the District of Columbia that will omit all drugs with an “orphan” designation from the 340B Drug Pricing Program for rural and cancer hospitals. Read More »

AstraZeneca said the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) about the new drug application (NDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin. The fixed-dose combination of saxagliptin and dapagliflozi is intended for the treatment of adult patients with Type 2 diabetes.  The CRL said more clinical data is required to support NDA. Read More »

The U.S. Food and Drug Administration gave accelerated approval to Praxbind (idarucizumab) on Oct. 16. Praxbind is intended for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. Praxbind and Pradaxa are marketed by Boehringer Ingelheim of Ridgefield, Connecticut. Read More »

The U.S. Food and Drug Administration on Friday approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Read More »

The American Society of Health-System Pharmacists (ASHP) has created a group of female industry leaders, which it named the Women in Pharmacy Leadership Steering Committee, to research and discuss the challenges and other issues women who work in the pharmacy field face regularly. Read More »

The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb Company’s Opdivo (nivolumab) injection for the treatment of patients with metastatic, non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Read More »

The apparently common practice of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is an unapproved use of these medical devices, the U.S. Food and Drug Administration said this week. Read More »

Merck KGaA, Darmstadt, Germany and Pfizer on Wednesday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to avelumab, a treatment for metastatic Merkel cell carcinoma. Read More »

The U.S. Food and Drug Administration (FDA) granted accelerated approval on Friday for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda, marketed by Merck, works by targeting the cellular pathway known as PD-1/PD-L1, which are proteins found on the body’s immune cells and some cancer cells. Through blocking this pathway, Keytr Read More »

Baxalta Inc. announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of an investigational 20 percent concentration immunoglobulin subcutaneous treatment. Read More »

The U.S. Food and Drug Administration (FDA) on Tuesday allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. Read More »

The U.S. Food and Drug Administration (FDA) and Novo Nordisk on Sept. 25 announced the approval of two products containing the long-acting human basal insulin and analog insulin degludec, to improve blood glucose control in adults with type 1 or 2 diabetes. Read More »

BD Life Sciences said late last week that it has completed its acquisition of Cellular Research, Inc.Cellular Research has developed advanced tools for massively parallel, single-cell genetic analysis based on its proprietary molecular Indexing technology, which enables gene-expression profiles from single cells Read More »

New types of insulin meant to improve blood sugar control in adults. Read More »

The U.S. Food and Drug Administration (FDA) recently approved Lonsurf, a drug for people who have an advanced form of colorectal cancer. Read More »

The U.S. Food and Drug Administration (FDA) recently agreed to review a New Drug Application (NDA) for Vesneo, an intraocular pressure-lowering, single-agent eye drop used once daily. Read More »

Vraylar proven to be effective in treating both mental health issues during extensive clinical trials. Read More »

Amicus Therapeutics on Tuesday announced that a pre-New Drug Application (NDA) meeting was held with the U.S. Food and Drug Administration (FDA) to discuss the oral, small-molecule pharmacological chaperone migalastat for the treatment of Fabry disease. Read More »