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...
FDA releases an FDA-483 with seven observations from an inspection at Union, NJ-based Ideal Pharmacy.
Federal Register notice: FDA announces that its Office of the Chief Scientist has modified its organizational structure.
The CDER Office of Pharmaceutical Quality issues a MAPP for its product quality assessors on consistent assessment of excess volumes in injectable dru...