FDA Decision Alert
CDER-Approved NDA for LUMAKRAS™ (sotarasib)
On May 28, 2021, FDA granted Accelerated Approval to Amgen’s LUMAKRAS™ (sotarasib) for ...
FDA Decision Alert
CBER-Approved sBLA for KEDRAB® (rabies immune globulin (human))
On May 17, 2021, FDA approved an sBLA for Kamada’s KEDRAB® (rabies immune globulin ...
FDA Decision Alert
CBER-Approved BLA for ABECMA® (idecabtagene vicleucel)
On March 26, 2021, FDA approved Celgene’s BLA for ABECMA® (idecabtagene vicleucel) for ...
FDA Decision Alert
CDER-Approved sBLA for ERBITUX® (cetuximab)
On April 6, 2021, FDA approved a new biweekly dosing regimen for Eli Lilly’s ERBITUX® ...
FDA Decision Alert
CDER-Approved NDA for VEKLURY® (remdesivir)
On October 22, 2020, the FDA approved Gilead Sciences’s VEKLURY® (remdesivir) for the ...
FDA Decision Alert
EMA-Approved application for ZOLGENSMA® (onasemnogene abeparvovec-xioi)
On March 26, 2020, the European Medicines Agency (EMA) approved AveXis’s ZOLGENSMA® ...
FDA Decision Alert
CDER-Approved NDA for EVRYSDI™ (risdiplam)
On August 7, 2020, the FDA approved Genentech’s EVRYSDI™ (risdiplam) “for the treatment ...
FDA Decision Alert
CDER-Approved NDA for BLENREP (belantamab mafodotin-blmf)
On August 5, 2020, the FDA approved GlaxoSmithKline (GSK)’s BLENREP (belantamab ...
FDA Decision Alert
CDER-Approved NDA for VILTEPSO® (viltolarsen)
On August 12, 2020, the FDA approved Nippon Shinyaku’s VILTEPSO® (viltolarsen) for ...
FDA Decision Alert
CDER-Approved sNDA for IBRANCE® (palbociclib)
On April 4, 2019, the FDA granted a label expansion to Pfizer’s IBRANCE® (palbociclib) ...
FDA Decision Alert
CDER-Approved NDA for AYVAKIT™ (avapritinib)
On January 9, 2020, the FDA approved Blueprint Medicines Corporation’s AYVAKIT™ ...
FDA Decision Alert
CDER-Approved NDA for KOSELUGO™ (selumetinib)
On April 10, 2020, the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) “for the ...
FDA Decision Alert
CDER-Approved NDA for TAZVERIK™ (tazemetostat)
On January 23, 2020, the FDA approved Epizyme’s TAZVERIK™ (tazemetostat) for patients “16 ...
FDA Decision Alert
CDER-Approved NDA for ONGENTYS® (opicapone)
On April 24, 2020, the FDA approved Neurocrine’s ONGENTYS® (opicapone) “as an adjunctive ...
FDA Decision Alert
CDER-Approved BLA for ENHERTU® (fam-trastuzumab deruxtecan-nxki)
On December 20, 2019, the FDA granted accelerated approval to Daiichi Sankyo’s ENHERTU® ...
FDA Decision Alert
CDER-Approved NDA for TABRECTA™ (capmatinib hydrochloride)
On May 6, 2020, the FDA approved Novartis’s TABRECTA™ (capmatinib hydrochloride) for ...
FDA Decision Alert
CDER-Approved NDA for ExEm® Foam (air polymer-type A) intrauterine foam
On November 7, 2019, the FDA granted approval of Giskit B.V.’s ExEm® Foam (air ...
FDA Decision Alert
CDER-Approved NDA for pretomanid tablets
On August 14, 2019, the FDA approved TB Alliance’s pretomanid tablets as part of a ...
FDA Decision Alert
CDER-Approved NDA for SCENESSE® (afamelanotide 16mg)
On October 8, 2019, the FDA granted approval to Clinuvel Pharmaceuticals Limited’s ...
FDA Decision Alert
CDER-Approved NDA for WAKIX® (pitolisant) tablets
On August 14, 2019, the FDA approved Harmony Biosciences’ WAKIX® (pitolisant) tablets, ...
FDA Decision Alert
CDER-Approved NDA for EGATEN™ (triclabendazole)
On February 13, 2019, the FDA approved Novartis’ EGATEN™ (triclabendazole), which was ...
FDA Decision Alert
CDER-Approved BLA for Jeuveau™ (prabotulinumtoxinA-xvfs)
On February 1, 2019, the FDA approved Evolus, Inc.’s Jeuveau™ (prabotulinumtoxinA-xvfs), ...