First-time generic approvals, June 2007

FDA Sets Date for Advisory Committee Meeting for Midomafetamine for PTSD

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.

May 8th 2024

FDA Accepts BLA for Pancreatic and Lung Cancer Therapy

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

FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease

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.

FDA Approves Liquid Mycophenolate to Prevent Organ Rejections

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.

FDA Assigns Action Date for Subcutaneous Opdivo

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

Administrative Issues Delay FDA Decision on Moderna RSV Vaccine

Bristol Myers Squibb is seeking approval of the subcutaneous formulation for all previous indications of Opdivo. The FDA has assigned a goal date of Feb. 28, 2025.

Related Content

May 10th 2024

FDA Sets Date for Advisory Committee Meeting for Midomafetamine for PTSD

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.

May 8th 2024

FDA Accepts BLA for Pancreatic and Lung Cancer Therapy

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

FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease

FDA Approves Liquid Mycophenolate to Prevent Organ Rejections

FDA Assigns Action Date for Subcutaneous Opdivo

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