Federal Register notice: FDA corrects a 5/11 notice entitled Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal.
FDA principal deputy commissioner Janet Woodcock and two other FDAers praise agency efforts to increase participation of women in clinical trials and ...
Three FDAers and a drug researcher give an overview of physiologically-based biopharmaceutics modeling.
ImmunityBio files a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Gurin (BCG) for treating BCG-unre...
Pfizer says a Covid vaccine booster shot was effective in kids 6 months to under age 5.
Researchers say drug companies are more likely to seek new formulations for blockbuster products and those given accelerated approval.
A European Medicines Agency committee says authorization of several generic medicines should be suspended because of questions about data submitted fo...
FDA denies a petition asking for restrictive agency actions on an NDA for Tyvaso.