ACADIA Pharmaceuticals Inc
NUPLAZID (sNDA)
FDA decision on NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis
04/03/2021
AVEO Pharmaceuticals, Inc.
Tivozanib (NDA)
FDA decision on Tivozanib treatment for relapsed or refractory renal cell carcinoma
03/31/2021
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA for Patients with High-Risk Early-Stage triple-negative breast cancer Based on KEYNOTE-522 Trial
03/29/2021
Bristol-Myers Squibb Co.
Idecabtagene vicleucel (BLA)
FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021
bluebird bio Inc.
Idecabtagene vicleucel (BLA)
FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021
CytRx Corp.
Arimoclomol (NDA)
FDA decision on Arimoclomol for the treatment of Niemann-Pick disease Type C
03/17/2021
Biogen Inc.
Aducanumab (BLA)
FDA decision on Aducanumab for Alzheimer's Disease
03/07/2021
KEMPHARM, INC
KMPH.OB
KP415 (NDA)
FDA decision on KP415 for the treatment of attention deficit hyperactivity disorder
03/02/2021
Blueprint Medicines
Pralsetinib (NDA)
FDA decision on Pralsetinib for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer
02/28/2021
CorMedix Inc.
Defencath (NDA)
FDA decision on Defencath for the prevention of catheter related blood stream infections
02/28/2021
Athenex, Inc.
Oral Paclitaxel in combination with Encequidar (NDA)
FDA decision on Oral Paclitaxel in combination with Encequidar for the treatment of Metastatic Breast Cancer
02/28/2021
Sarepta Therapeutics
Casimersen (NDA)
FDA decision on Casimersen for DMD amenable to Exon 45 skipping
02/25/2021
Bristol-Myers Squibb Co.
OPDIVO (sBLA)
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
02/20/2021
Exelixis, Inc.
CABOMETYX (sNDA)
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
02/20/2021
TG Therapeutics Inc.
Umbralisib (NDA)
FDA decision on Umbralisib as a treatment for for patients with previously treated marginal zone lymphoma
02/15/2021