Akorn through its bankruptcy (Chapter 7) trustee recalls various within-expiry human and animal products because the company has ceased all operations...
FDA approves a Vertex Pharmaceuticals supplemental NDA for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor) to include certain children...
FDA issues a warning about adverse event reports related to selective androgen receptor modulators (SARMs), which are often marketed as dietary supple...
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...
