FDA approves OTC Nexium

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.

FDA Converts Tivdak’s Accelerated Approval to Full Approval for Cervical Cancer

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.

April 30th 2024

FDA Sets Date for Advisory Committee Meeting for Midomafetamine for PTSD

A phase 3 trials showed Tivdak demonstrated a 30% reduction in the risk of death. The U.S. list price is $6,599 per 40 mg single dose vial.

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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.

FDA Converts Tivdak’s Accelerated Approval to Full Approval for Cervical Cancer

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.

April 30th 2024