FDA approves AztraZeneca and Marcks Lynparza for treating patients with a specific form of prostate cancer.
FDA conditionally accepts Gimoti as the brand name for an Evoke Pharma diabetic gastroparesis nasal spray product.
FDA issues a guidance on adverse event reporting priorities during the Covid-19 pandemic.
FDA issues a guidance recognizing donor history questionnaires prepared by the Plasma Protein Therapeutics Association.
FDA commissioner Stephen Hahn says CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves from all regulatory consideration...
Federal Register notice: FDA announces a 6/4-5 public Web conference to discuss the International Council for Harmonizations good clinical practice gu...
Karyopharm Therapeutics files a supplemental NDA for Xpovio (selinexor), indicated as a new treatment for patients with previously treated multiple my...
AdvaMed joins two national health organizations in suggesting guidelines for allowing medical device company representatives back into hospitals and o...