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Company Name Ticker Drug Event Date Outcome Details

CytRx Corp. CYTR Arimoclomol (NDA) FDA decision on Arimoclomol for the treatment of Niemann-Pick disease Type C 03/17/2021 -Drug Status





Biogen Inc. BIIB Aducanumab (BLA) FDA decision on Aducanumab for Alzheimer's Disease 03/07/2021 -Drug Status





CorMedix Inc. CRMD Defencath (NDA) FDA decision on Defencath for the prevention of catheter related blood stream infections 02/28/2021

Athenex, Inc. ATNX 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 -Drug Status





Blueprint Medicines BPMC 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 -Drug Status



-Approved in Other Countries





Sarepta Therapeutics SRPT Casimersen (NDA) FDA decision on Casimersen for DMD amenable to Exon 45 skipping 02/25/2021 -Drug Status





TG Therapeutics Inc. TGTX , TGTX.OB Umbralisib (NDA) FDA decision on Umbralisib as a treatment for for patients with previously treated marginal zone lymphoma 02/15/2021 -Drug Status





G1 Therapeutics, Inc. GTHX Trilaciclib (NDA) FDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapy 02/15/2021 -Drug Status





Mallinckrodt plc MNK StrataGraft (BLA) FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns. 02/02/2021 -Drug Status





Adamas Pharmaceuticals Inc ADMS GOCOVRI (sNDA) FDA decision on GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy 02/01/2021

Adamas Pharmaceuticals Inc ADMS GOCOVRI (sNDA) FDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy 02/01/2021 -Approved in Other Countries





Protalix BioTherapeutics Inc. PLX PRX–102 (BLA) FDA decision on PRX–102 for the treatment of Fabry disease 01/27/2021

Aurinia Pharmaceuticals Inc. AUPH , AUP.V Voclosporin (NDA) FDA decision on Voclosporin for the treatment of lupus nephritis 01/22/2021 -Drug Status





Merck & Co Inc. MRK Vericiguat(NDA) FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection Fraction 01/20/2021 -Drug Status



