Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new Loper Bright Suprem...
Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses.
FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Sterilization Products S...
Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks semaglutide, the acti...
FDA renews the Drug Safety and Risk Management Advisory Committee for an additional two years.
FDA grants Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay.
FDA updates an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021.
FDA grants META Pharmaceuticals a rare pediatric disease designation for META-001-PH, an investigational drug for treating primary hyperoxaluria.
