December 22, 2020 – The U.S. FDA has approved a new indication for Kineret® (anakinra), manufactured
by Sobi. The drug is now indicated to treat deficiency of IL-1 receptor antagonist.
December 22, 2020 – The U.S. FDA has approved an expanded indication for Vaxchora® (cholera vaccine,
live) oral suspension, manufactured by Emergent Travel Health. The vaccine, which
December 21, 2020 – The U.S. FDA has granted Emergency Use Authorization (EUA) to Moderna for a vaccine to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals who are least 18 years
December 21, 2020 – The U.S. FDA has approved EbangaTM (ansuvimab), manufactured by Ridgeback
Pharmaceuticals, to treat Zaire ebolavirus infection (Ebola) in adults and children. Ebanga is
December 21, 2020 – The U.S. FDA has approved an expanded chronic sialorrhea indication for Xeomin®
(incobotulinumtoxinA), manufactured by Merz Pharmaceuticals. Previously approved to
December 21, 2020 – The U.S. FDA has approved a new indication for Arcalyst (rilonacept), manufactured by Regeneron. The drug is now indicated for maintenance of remission of deficiency of
December 21, 2020 – The U.S. FDA has approved expanded indications for three medications from Vertex
Pharmaceuticals that are indicated to treat cystic fibrosis (CF), with patients selected
December 18, 2020 – The U.S. FDA has approved Orgovyx TM (relugolix), manufactured by Myovant
Sciences, as the first oral hormone therapy indicated to treat advanced prostate