December 22, 2020
In December 2020, the U.S. FDA granted Emergency Use Authorization to Pfizer/BioNTech and Moderna for vaccines to prevent COVID-19 caused by SARS-CoV-2 infection. Moderna’s vaccine is indicated for use in individuals 18 and up
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December 22, 2020
Adverse reactions or quality problems experienced with the use of a recalled product can be
reported to the FDA’s MedWatch Adverse Event Reporting
December 22, 2020
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
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
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
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
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
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