FDA Drug Approvals

Company Name

Drug

Event

Outcome

Details

Catalyst Pharmaceutical Partners Inc.
(CPRX)

Firdapse (sNDA)

Q4 2022
FDA decision on Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) pediatric patients

FDA approved Firdapse for the treatment of Lambert-Eaton myasthenic syndrome in pediatric patients on Sep.29, 2022-

Rival Drugs

Approved in Other Countries

AstraZeneca PLC
(AZN.L, AZN)

Tremelimumab(BLA)

Q4 2022
FDA decision on Tremelimumab in combination with Imfinzi for the treatment of patients with unresectable hepatocellular carcinoma

Drug Status

Rival Drugs

Sanofi
( SNYNF, SNY)

Xenpozyme (BLA)

10/03/2022
FDA decision on Xenpozyme for the treatment of acid sphingomyelinase deficiency

FDA approved Xenpozyme for the treatment of acid sphingomyelinase deficiency on Aug.31, 2022-

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