Former FDAer Peter Pitts asks if FDA is going too far in seeking deference in a court case involving Regenative Labs Whartons Jelly Tissue Allografts....
The Justice Department says former Dolor Technologies CEO Mark Wright has pleaded guilty to misdemeanor charges of introducing adulterated and misbran...
CDER asks for comments on barriers and facilitators to incorporating innovative clinical trials in drug development programs.
Verrica Pharmaceuticals asks FDA to take steps to stop the compounding of its Ycanth molluscum contagiosum treatment.
FDA releases the form FDA-483 with six observations from an inspection at the Samsung Biologics drug manufacturing facility in Incheon, Korea.
FDA grants Diakonos Oncology a fast-track designation for the companys dendritic cell vaccine, DOC1021, for use in patients with glioblastoma multifor...
PhRMA calls on the Supreme Court to hear a Danco Laboratories/FDA appeal of a 5th Circuit Court of Appeals decision restricting use of the abortifacie...
FDA denies without comment the specific requests in a UCB petition asking the agency to not approve an Apotex ANDA for generic Fintepla unless specifi...
