FDA asks the Oncologic Drugs Advisory Committee whether an sNDA for AstraZenecas prostate cancer drug olaparib in combination with Janssens abirateron...
FDA lifts a 2021 Warning Letter to Medtronic that followed an inspection of the companys diabetes headquarters in Northridge, CA.
FDA warns London, UK-based Medivance Instruments about multiple violations in its manufacturing of the Velopex AquaCare line of dental abrasion produc...
FDA warns Burbank, CA-based Medolife Rx that it is illegally marketing several unapproved new homeopathic drug products.
FDA Oncology Division director Harpreet Singh cautions on discomfort that clinical investigators may feel about the agencys efforts to streamline onco...
FDA grants Biogen accelerated approval for Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis associated with superoxide dismutas...
FDA lifts its clinical hold against a MaaT Pharma IND for an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy ...
Senate HELP Committee leaders reach a legislative bipartisan deal to expand the availability of low-cost generic drugs, clarify orphan drug exclusivit...
