Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bioequivalence studies...
Takeda says it is moving its narcolepsy Type 1 drug TAK-861 to a Phase 3 trial after reporting positive results from a Phase 2b trial.
FDA clears a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system.
Federal Register notice: FDA debars Shanif Abdul Punjani for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA issues an order debarring Michael Terry Little for five years from importing or offering for import any drug into the U.S...
Agios Pharmaceuticals plans to submit by the end of the year an NDA for mitapivat and its use on adults with transfusion-dependent alpha- or beta-thal...
FDA places a partial clinical hold on a Blueprint Medicines early-stage trial testing its experimental cancer drug because of safety concerns.
FDA extends by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult pa...
