FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorlin Syndrome.
A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 American overdose deaths.
Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent infringement action wa...
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.
FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaph...
FDA Review posts the Federal Register notices for the week ending 11/17/2017.
FDA releases a guidance on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation a...
Congresswoman Rosa DeLauro (D-CT) reintroduces a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug ...