FDA qualifies the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools p...
Serenity Pharmaceuticals petitions FDA to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treat...
FDA posts an Akorn Form 483 from a 2016 inspection at the firms Zurich, Switzerland sterile drug manufacturing facility.
FDA Review posts the Federal Register notices for the week ending 5/5/2019.
FDA approves a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot...
FDA withdraws three Sun Pharmaceutical Industries ANDAs because they are no longer marketed.
Federal Register notice: FDA withdraws the approval of nine ANDAs from multiple applicants.
Federal Register notice: FDA issues a final order to reclassify the needle destruction device into Class 2 (special controls)and subject to premarket ...