A California federal court dismisses PhRMAs suit against a state drug pricing transparency law and gives the association an opportunity to amend its c...
FDA clears a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of advanced bioabsorbable technologies for reconstructive an...
FDA says it will continue to monitor research into quantifying live microbial dietary ingredients in probiotics rather than approve a petition seeking...
FDA commissioner Scott Gottlieb announces a revised memorandum of understanding to be signed with states that want to collaborate with the agency in i...
FDA sets a 10/19 public meeting on standardized data for electronic submission of Pharmaceutical Quality/Chemistry Manufacturing and Control data.
FDA airs concerns about misconnections with enteral devices.
FDA clears an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex reti...
FDA approves Tevas Cassipa, a stronger dose of buprenorphine and naloxone sublingual film for maintenance treatment of opioid dependence.