A CDER drug approval annual report discusses the 50 new therapies approved by the Center in 2021.
The U.S. Federal Circuit Court of Appeals upholds a lower court decision that found valid a Novartis patent covering a dosing regimen for Gilenya (fin...
n-Lorem Foundation says a new FDA guidance on antisense oligonucleotides will help it develop new treatments for nano-rare patients.
Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biological products woul...
The Council for Responsible Nutrition says FDA failed to respond to its legal inquiry on the agencys policy shift involving marketing dietary suppleme...
The Justice Department says a federal grand jury indictment charges a North Carolina doctor with multiple offenses related to Medicare billing for bal...
FDA clears the VySpine VySpan posterior cervical thoracic system.
Federal Register notice: FDA announces that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures.