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January 08, 2024
Societal™ CDMO's J. David Enloe and Erica Raether discuss the fundamentals of maintaining a strong company culture during times of change.
July 28, 2023
Pandemic, PBM, and other policies on hold during the summer recess.
July 11, 2023
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
June 16, 2023
There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.
June 05, 2023
Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.
May 26, 2023
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.
April 24, 2023
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.
April 10, 2023
Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?
April 07, 2023
The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.