Moderna says it has begun dosing participants in its Phase 3 study of its mRNA vaccine candidate for Covid-19.
Indivior Solutions pleads guilty to one felony count and agrees to pay a total of $600 million to resolve criminal and civil liability associated with...
FDA requests additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the companys Phase 1-2 IGNITE...
FDA reissues an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use testing for asymptomatic p...
FDA clears a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency heat lesion procedures for relieving pain.
FDA approves an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with ...
FDA grants MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treating symptomatic, obst...