Former FDA Oncologic Drugs Advisory Committee chairman Mikkael Sekeres looks at seven ways in which sponsor committee presentations can create problem...
FDA announces a 3/22 Peripheral and Central Nervous System Drugs Advisory Committee to review Biogens tofersen, an investigational new drug intended t...
Verrica Pharmaceuticals resubmits an NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an in...
AdvaMed gives the Biden Administration three points to consider as it works with EPA to finalize an updated standard for ethylene oxide emissions from...
A detailed ProPublica analysis says lobbying by several interests killed the inclusion of the VALID act to regulate laboratory-developed tests in the ...
Medical school researchers say most DTC ads are for drugs that do not represent an advance over existing treatments.
FDA warns the South Miami, FL-based Larkin Community Hospital institutional review board about failing to adhere to statutory and regulatory requireme...
After three failed submissions, FDA accepts for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release table...
