FDA-backed Critical Path Institutes Transplant Therapeutics Consortium submits the iBox Scoring System for CDERs Biomarker Qualification Program.
FDA says it is participating in a new Diagnostics Evidence Accelerator focusing on using real-world data to answer questions about Covid-19 antibodies...
FDA updates its list of off-patent, off-exclusivity drugs for which there is no approved generic product.
CDER issues a MAPP with procedures for determining the need for and components of a new REMS for drug products approved through an NDA or BLA.
A petition to FDA submitted by a physician asks the agency to include in opioid Boxed Warnings and package inserts HHS language encouraging doctors to...
Former FDA acting chief scientist Luciana Borio tells Barrons FDA leadership needs to work to regain public trust so that people will believe in the s...
FDA approves an Ultragenyx Pharmaceutical and Kyowa Kirin supplemental BLA for Crysvita (burosumab) for treating fibroblast growth factor 23-related h...
FDA approves a label update for Almiralls Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for developing resistance to ...