Federal Register notice: FDA makes available a draft guidance entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmet...
FDA approves a Foresee Pharmaceuticals NDA for Camcevi (leuprolide mesylate) 42 mg for treating advanced prostate cancer.
The Federal Trade Commission asks the Supreme Court not to hear AbbVies appeal of lower court decisions holding that it engaged in sham litigation to ...
The Justice Department says a Georgia man has been sentenced to five years probation for conspiracy to distribute unapproved drugs and unlawful smuggl...
FDA grants an EUA for Sotrovimab, a monoclonal antibody treatment for Covid-19 developed by Vir Biotechnology and GlaxoSmithKline.
U.S. Department of Justice issues a subpoena to Eli Lilly requesting documents about its troubled manufacturing site in Branchburg, NJ.
FDA approves Progenics Pharmaceuticals Pylarify for PET imaging of prostate-specific membrane antigen positive lesions in some men with prostate cance...
FDA cautions New York Citys Metro Drug about adulterated and misbranded sterile drug products.