FDA approves a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with a vaginal yeast infection.
The Council for Responsible Nutrition says FDA should revert to its prior policy allowing NAC to be sold as a dietary supplement.
FDA acting commissioner Janet Woodcock says biosimilar product development is maturing with the help of numerous initiatives at the agency.
FDA warns Utah Cord Bank about significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products.
The FDA Oncology Center of Excellence says it is using crowdsourcing to generate possible research questions for agency scientific staff to pursue usi...
FDA extends by three months its review of Verrica Pharmaceuticals NDA for VP-102 (cantharidin), a combination drug-device for treating molluscum conta...
FDA warns DeChoker about Quality System regulation violations in its production of a tracheobronchial suction device.
Federal Register notice: FDA determines that Novartis Sandostatin (octreotide acetate) injection was not withdrawn for safety or effectiveness reasons...