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April 18, 2023
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of...
April 17, 2023
U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023 European Medicines Agency has... | April 17, 2023
April 17, 2023
U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023European Medicines Agency has validated Bristol Myers Squibb’s Type II variation application for AbecmaBristol Myers Squibb’s supplemental New Drug Applicatio...
April 17, 2023
On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key...
April 14, 2023
As the nation grapples with continuing changes in court rulings affecting the U.S. Food and Drug Administration’s approval of a drug used in abortion care, Washington state’s competing lawsuit and other offensive and defensive moves related to abortion are working exactly as officials and advocates say they intended.