A Science investigative report details the large percentage of clinical trials that fail to meet legal requirements for submitting data and results an...
FDA warns Health Pharma about CGMP violations in its work as a contract manufacturer of finished drugs.
Ultragenyx Pharmaceutical and Kyowa Kirin file a supplemental BLA for Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with...
FDA releases its latest batch of Warning Letters that includes Health Pharma, Huaian Zongheng Bio-Tech and James W. Findling.
FDA warns Chinas Huaian Zongheng Bio-Tech about CGMP violations in its work as a contract producer of finished drugs.
Vifor asks FDA to restrict the approval pathway for harder-to-copy complex drugs such as its products treating iron deficiency.
FDA denies a petition asking it not to approve an NDA for Neurelis Valtoco, and approves the NDA.
Former FDA principal deputy commissioner Joshua Sharfstein calls for reforms to the agencys decades of drug regulation reform to increase the effectiv...