FDA approves an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in pediatric pat...
Medtronic recalls its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the devices Biopsy Depth Gauge Cy...
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Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biological products woul...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...