Xyrem (Sodium oxybate (gamma hydrobutyrate [GHB])) Orphan Medical Inc

If approved, the Leqembi autoinjector could be used to administer the treatment for Alzheimer’s disease at home or at medical facilities.

Regulators are now working to complete their review of the BLA for mRNA-1345 by the end of May 2024. mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices in June 2024.

If approved, midomafetamine would be the first psychedelic-assisted therapy approved for any mental health condition. The advisory committee meeting is June 4, 2024.

Zenocutuzumab is a new type of bispecific antibody that target both HER2 and HER3 proteins to inhibit NRG1 binding and blocking the mechanism for tumor survival. The FDA’s target date is in December 2024.

The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday, June 10, 2024, to discuss the phase 3 trial of Lilly’s donanemab to treat patients with early symptomatic Alzheimer’s disease.

Myhibbin is a ready-to-use mycophenolate mofetil oral suspension to prevent rejection of kidney, heart and liver transplants.