FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.
The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.
FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.
FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods used to evaluate bi...
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
