The FDA has expanded approval of a hemophilia treatment developed by Pfizer to include pediatric patients ages 6-11 with or without inhibitors and for patients 12 and older with inhibitors. The expanded indication covers routine prophylaxis to prevent or reduce…
Pharmacy
A federal judge has dismissed with prejudice AbbVie’s lawsuit challenging Mississippi’s Defending Affordable Prescription Drug Costs Act, granting summary judgment to Mississippi Attorney General Lynn Fitch, according to a June 3 final judgment. AbbVie and several affiliated companies sued Mississippi…
Drugmakers, patient advocates and public health experts have urged the FDA to pause or significantly revise its priority voucher program during the agency’s first public hearing on the initiative June 4. Critics cited concerns about transparency, political influence and the…
The FDA’s Center for Drug Evaluation and Research has accepted the first letter of intent for an in silico drug development tool into the agency’s Innovative Science and Technology Approaches for New Drugs qualification program. The tool, an AI-Driven Digital…
When compared to chemotherapy, a drug targeting oncogenic RAS mutations extended overall and progression-free survival for patients with metastatic pancreatic cancer, according to a study published May 31 in The New England Journal of Medicine. The third-leading cause of cancer…
The Supreme Court has unanimously ruled that generic drugmakers cannot be sued for patent infringement simply because their marketing materials don’t spell out every limitation of their FDA approval — a decision that clears a significant legal cloud over a…
Winston-Salem, N.C.-based Novant Health has launched NovaCatalyst, a venture designed to expand its pharmacy and imaging services to healthcare organizations nationwide. NovaCatalyst will support the growth of MedVenta, a provider-led pharmacy solutions company, and MedQuest Imaging, an outpatient imaging provider,…
Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to the American Society of Health-System Pharmacists — and the FDA’s database continues to reflect new discontinuations weekly. The…
Rockford, Ill.-based Mercyhealth has opened a retail pharmacy in Beloit, Wis., expanding prescription access for patients on the Illinois-Wisconsin border. The pharmacy offers prescription filling, medication counseling, prescription transfers and refill services. A drive-thru lane is available for patients seeking…
In April, the FDA debuted a real-time clinical trial model that will allow the agency to monitor safety signals as the trial is being conducted. The first trials were launched in partnership with Houston-based University of Texas MD Anderson Cancer…