Company Name
Drug
Event
Outcome
Details
GlaxoSmithKline PLC
(GSK.L, GSK)
Cabenuva (resubmitted NDA)
Mid 2021
FDA decision on Cabenuva to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
FDA approved Cabenuva on Jan.21, 2021-
Roche Holding AG
(RHHBY)
Esbriet (sNDA)
May 2021
FDA decision on Esbriet for the treatment of unclassifiable interstitial lung disease
-
ChemoCentryx Inc.
(CCXI)
Avacopan (NDA)
05/06/2021
FDA panel to review Avacopan for the treatment of ANCA-associated vasculitis,
-
Read More Get Access to Premium FDA Calendar with RTT Biotech Investor.