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.
Attorney Faraz Siddiqui explains provisions of the revised PhRMA Code on company interactions with healthcare practitioners and why companies may want...
FDA removes a Spero Therapeutics clinical hold on a Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycoba...
FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for mission-critical inspections because of safet...