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...
Four stakeholders give FDA recommendations for changes to a draft guidance on flow restrictors for oral liquid drug products.
Federal Register notice: FDA announces the renewal of the Arthritis Advisory Committee for an additional two years beyond the charter expiration date.
FDA publishes a list of eight information collections recently approved by OMB.
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.