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...
FDA grants ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring an...
House Energy and Commerce Committee Republican leaders say they are renewing a 2018 investigation into three opioid manufacturers to get all the infor...