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FDA has approved patisiran (Onpattro—Alnylam Pharmaceuticals) infusion for the treatment of peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adults. This is the first FDA-approved treatment for individuals with polyneuropathy caused by hATTR.
In a statement, FDA Commissioner Scott Gottlieb discusses the agency's efforts to recognize the role that more novel forms of nicotine delivery could play in achieving public health goals.
FDA on Friday said it "wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA." The agency announced on July 13 a recall of particular batches of valsartan tablets due to an impurity, the chemical N-nitrosodimethylamine (NDMA).
FDA approved on Friday ivosidenib (Tibsovo—Agios Pharmaceuticals) tablets for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have a particular genetic mutation. The drug is approved for use with an FDA companion diagnostic used to identify specific mutations in the IDH1 gene in patients who have AML.
FDA has approved tecovirimat (TPOXX—SIGA Technologies Inc.), the first drug with an indication for treatment of smallpox, the agency said Friday. The World Health Organization declared smallpox eradicated in 1980; however, there is concern that it could be used as a potential bioweapon.
Adding pharmacists to a team-based care practice model has benefited the Providence Medical Group in Oregon for more than 2 decades, as they target conditions including diabetes, asthma, and hypertension. During that time, Providence increased its number of pharmacists from 1 to 21 in more than 40 patient-centered medical homes.
The Trump administration has proposed transferring most of the responsibility for regulating food safety from FDA to the Department of Agriculture (USDA), and to rename FDA the "Federal Drug Administration." The proposal is part of a plan released Thursday that includes other broader ideas to reform HHS, including renaming it the "Department of Hea
FDA approved Thursday the first generic versions of buprenorphine and naloxone (Suboxone—Indivior) sublingual film for the treatment of opioid dependence. Mylan Technologies and Dr. Reddy's Laboratories received FDA approval to market buprenorphine and naloxone sublingual film in multiple strengths.
A new CDC and FDA survey reveals that the number of U.S. middle and high school students who are using tobacco products has declined, but the number is still too high.
FDA Commissioner Scott Gottlieb, MD, released Thursday a statement regarding some brand-name drug makers' use of Risk Evaluation and Mitigation Strategy (REMS) requirements to block generic drugs from making a timely entry to market.