The FDA has approved Merck’s Enflonasia, a monoclonal antibody designed to prevent respiratory syncytial virus lower respiratory tract disease in newborns and infants. The approval is based on data from a phase 2b/3 trial, which showed a 60.5% reduction in…
Pharmacy
The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA Commissioner Marty Makary, MD, and Vinay…
In the first half of 2025, Mark Cuban’s Cost Plus Drugs Co. has expanded operations across its drug manufacturing, distribution and partnership enterprises. The company continues to grow its presence in the generic drug market while also working to promote…
The FDA has approved a revised label for Merck’s immunotherapy drug Keytruda, limiting its use in some gastrointestinal cancer treatments to patients whose tumors express a minimum level of PD-L1 protein. The updated prescribing information now restricts first-line use of…
In 2024, the cost and utilization of specialty dermatology drugs significantly drove a 7% increase in pharmaceutical costs, according to a June 10 report from Navitus Health Solutions, a pharmacy benefits manager. Although specialty medications accounted for less than 2%…
The American Pharmacists Association is withholding its endorsement of the latest adult immunization schedule issued by the CDC’s Advisory Committee on Immunization Practices. After recent updates by HHS and CDC removed the recommendation for COVID-19 vaccination during pregnancy, the APhA…
Giant Eagle is taking over the prescriptions from 78 Rite Aid pharmacies across Pennsylvania and Ohio as Rite Aid shutters locations following its bankruptcy filing, CBS News reported June 6. The regional grocer and pharmacy chain announced last week it…
Mather Hospital in Jefferson, N.Y., part of New Hyde Park, N.Y.-based Northwell Health, is launching a pharmacy residency program July 1, expanding its graduate medical education offerings. The one-year program will train post-graduate pharmacy residents in their first year in…
Here are seven new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists. Editor’s note: The drugs listed are in alphabetical order
The FDA is urging lawmakers to reauthorize a key user fee program that could expand access to over the counter medications, reducing barriers to treatment. At a recent hearing before the Senate Health, Education, Labor and Pensions Committee, FDA officials…