Regulatory Oversight and Compliance

FDA Grants Breakthrough Therapy Designation to SAB Biotherapeutics for Influenza Immunotherapy

April 20, 2023

SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

FDA’s Office of New Drugs Highlights New Research Projects for Growth

April 18, 2023

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

AbbVie Receives European Commission Approval for Crohn’s Disease Therapeutic

April 18, 2023

AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.

FDA Approves Gamida Cell’s Cell Therapy for Treating Blood Cancers

April 18, 2023

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Caribou Biosciences Gets FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy

April 14, 2023

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

FDA Commissioner and Chief Scientist Withdraw Approval of Makena

April 12, 2023

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority

April 11, 2023

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

FDA Regulatory Authority Under Attack

April 10, 2023

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

FDA Is Hiring!

April 07, 2023

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

FDA Backs Randomized Trials for Accelerated Drug Approval

April 07, 2023

FDA aims to address mounting criticisms of its accelerated approval pathway.