FDA approves Sanofis Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not ad...
Outlook Therapeutics says it has withdrawn a BLA submitted in March for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration ...
FDA posts information on accreditation body participation in the Accreditation Scheme for Conformity Assessment pilot program.
FDA grants Allogene Therapeutics a regenerative medicine advanced therapy designation for ALLO-501A in relapsed/refractory large B cell lymphoma.
FDA says a Medtronic recall of its HVAD pump implant kit due to a pump weld defect is Class 1.
FDA says it is considering implementing a master file pilot program for PMA holders whose approved devices are sterilized using radiation.
Federal Register notice: FDA posts a list of PMAs that have been approved from 1/1/2021 through 2/14/2022 that have safety and effectiveness summaries...
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at...
