The FDA has again paused Regenxbios RGX-121 gene therapy trial for Hunter syndrome after small, asymptomatic masses were found on the spines of five patients. Regenxbio does not expect to resubmit its biologics license application for the therapy in the…

Prestige Brands Holdings is voluntarily recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief due to a lack of assurance of sterility. Prestige initiated the recall July 29. The FDA classified it as Class II on Aug. 14, meaning…

The FDA has approved six new treatments across oncology, neurology and cardiometabolic care in recent weeks, with one rare disease decision window still ahead.  Here are six approvals to know:

A federal judge has ordered 340B certifications for 11 clinics to be set aside after finding they did not meet statutory requirements for participation in the drug discount program. The U.S. District Court for the District of Columbia on Aug.…

Milwaukee-based Children’s Wisconsin became the first center in the U.S. to administer Otarmeni, an FDA-approved gene therapy for genetic hearing loss, outside a clinical trial. The health system treated two children with the therapy. The health system is one of…

The FDA granted accelerated approval to Ultragenyx Pharmaceutical’s Genglycos, the first approved treatment for glycogen storage disease type Ia. The one-time AAV8-based gene therapy is approved to reduce daily cornstarch intake as an adjunct to nutritional management in adults and…

The Pharmaceutical Care Management Association and its members committed to sharing TrumpRx’s cash prices for drugs through their real-time benefit tools and other cost transparency platforms. An Aug. 13 news release said the association coordinated with the Trump administration and CMS Administrator…

Hospitals and health systems are pouring capital into pharmacy operations this summer, from rural cardiology partnerships to $30 million automated fulfillment centers, as they look to capture more prescription volume, cut readmissions and compete with retail pharmacy closures. Here’s a…

When combined with immunotherapy, an mRNA-based vaccine has been found to cut the risk of melanoma recurrence and distant metastasis more than immunotherapy alone. Results from the phase 3 trial of the vaccine, called intismeran, will be presented at an…

Pittsburgh-based Allegheny Health Network has saved $4.2 million and significantly reduced medication stockouts after shifting from managing pharmacy inventory at individual hospitals to an enterprisewide strategy, according to Laura Mark, PharmD, vice president of pharmacy. Speaking on Becker’s “Pharmacy Leadership…