Company Name
Drug
Event
Outcome
Details
Adamas Pharmaceuticals Inc
(ADMS)
GOCOVRI (sNDA)
02/01/2021
FDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
FDA approved GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy on Feb.1, 2021-
Mallinckrodt plc
(MNK)
StrataGraft (BLA)
02/02/2021
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
-
Merck & Co Inc.
(MRK)
KEYTRUDA (sBLA)
02/09/2021
FDA panel to review to review Keytruda as adjuvant therapy for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC),
FDA panel recommends against approval of Keytruda as adjuvant therapy for the treatment of patients with high-risk early-stage triple-negative breast cancer-
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