Panelists at a conference debate the value of clinical efficacy studies to determine biosimilar bioequivalence.
Akebia Therapeutics submits an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia d...
HHS publishes its semiannual regulatory agenda including six final rules and four completed actions from FDA.
Former CDER associate director Jonathan Sackner-Bernstein lists five traits the Biden administration should want in an FDA commissioner.
FDA grants Biom Therapeutics an orphan drug designation for BIO017 and its use in treating Angelman syndrome.
FDA launches a new Web page for clinical lab staff and healthcare providers on the impact of viral mutations on Covid-19 tests.
CDRH says it will hold a two-day meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel to review information about the b...
FDA releases its latest batch of Warning Letters that includes one medical product company PYRLess Group.