FDA Novel Drug Approvals – March 2023

Apr 032023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta

FDA Novel Drug Approvals – February 2023

Mar 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia Drug Trials

FDA Novel Drug Approvals – January 2023

Feb 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Orserdu elacestrant 1/27/2023 To treat estrogen receptor-positive, human epidermal

FDA Novel Drug Approvals – December 2022

Jan 032023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot NexoBrid anacaulase-bcdb 12/28/2022 To remove eschar in adults with

FDA Novel Drug Approvals – November 2022

Dec 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Tzield teplizumab-mzwv 11/18/2022 To delay the onset of stage

FDA Novel Drug Approvals – October 2022

Nov 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Tecvayli teclistamab-cqyv 10/25/2022 To treat relapsed or refractory multiple

FDA Novel Drug Approvals – September 2022

Oct 032022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Lytgobi futibatinib 9/30/2022 To treat intrahepatic cholangiocarcinoma harboring fibroblast

FDA Novel Drug Approvals – August 2022

Sep 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Xenpozyme Olipudase alfa 8/31/2022 To treat Acid Sphingomyelinase Deficiency

FDA Novel Drug Approvals – June 2022

Jul 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Amvuttra vutrisiran 6/13/2022 To treat polyneuropathy of hereditary transthyretin-mediated

FDA Novel Drug Approvals – May 2022

Jun 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Vtama tapinarof 5/23/2022 To treat plaque psoriasis Drug Trials

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