Pharmacy

The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development. ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from…

Tampa, Fla.-based Moffitt Cancer Center has launched a radiopharmaceutical program at its Land O’ Lakes, Fla.-based research facility and medical campus, Speros. The program will focus on radiopharmaceutical research, development, clinical translation and manufacturing. The program will be led by…

Pediatric medications have more active FDA-listed shortages than any other therapeutic category, according to the FDA’s drug shortage database. Here are the categories with the most active shortage listings, ranked by number of active shortages as of Aug. 25: 1.…

OhioHealth Morrow County Hospital in Mount Gilead, Ohio, is switching its automated dispensing cabinets to Omnicell as part of the health system’s broader push to improve medication safety. The upgrade allows any OhioHealth hospital to view the medications available at…

Mark Cuban Cost Plus Drug Co. has partnered with RxSaveCard and nonprofit Golden Thread to streamline sourcing and reduce costs of pediatric cancer clinical trial medications.  Once enrolled in a study, patients will sign up for RxSaveCard and receive trial…

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…