August 19, 2020 – The U.S. FDA has approved Mylan’s generic version of Tecfidera® (dimethyl fumarate –
Biogen) delayed release 120mg and 240mg capsules. Dimethyl fumarate
August 19, 2020 – The U.S. FDA has approved an expanded indication for Xeomin® (incobotulinumtoxinA)
intramuscular or intraglandular injection, manufactured by Merz Pharmaceuticals.
August 17, 2020 – The U.S. FDA has approved EnspryngTM (satralizumab-mwge), manufactured by
Genentech, to treat neuromyelitis optica spectrum disorder (NMOSD) in adult
August 12, 2020 – The U.S. FDA has approved ViltepsoTM (viltolarsen), manufactured by NS Pharma, to
treat Duchenne muscular dystrophy (DMD) in patients who have
August 10, 2020 – The U.S. FDA has approved OlinvykTM (oliceridine) injection, manufactured by Trevena,
for use in adults for whom alternative treatments are inadequate to manage
August 7, 2020 – The U.S. FDA has approved Lampit® (nifurtimox), manufactured by Bayer, to treat
pediatric patients who weigh at least 2.5kg (5.5 pounds) and
August 7, 2020 – The U.S. FDA has approved EvrysdiTM (risdiplam), manufactured by Genentech, to treat spinal muscular atrophy (SMA) in patients who are at least two months old.
August 6, 2020 – The U.S. FDA has approved BlenrepTM (belantamab mafodotin-blmf), manufactured by
GlaxoSmithKline, for use as a single agent to treat adults who have