SPOTLIGHT -
First combination approved specifically for bipolar depression
FDA Clears Narcan OTC for Opioid Overdoses
Emergent BioSolutions hasn’t provided a price for the nonprescription Narcan but said the product will be available by late summer.
FDA Schedules Advisory Committee Meeting for OTC Contraceptive
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
FDA Approves First Treatment for Rare Immunodeficiency Disease
Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
FDA Rejects NDA for Extended-Release Jakafi
Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
