FDA accepts for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for preventing migraine...
FDA approves a four-year clinical trial using CRISPR gene editing to cure sickle cell disease.
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.