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TVTX stock falls as FDA extends review timeline for Filspari sNDA
Shares of Travere Therapeutics TVTX were down 14.6% on Tuesday after the company announced that the FDA had extended the ...
Stocktwits on MSN
Travere Therapeutics stock slumps after FDA extends drug review timeline to April: Retail is divided on eventual approval
The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit.
Travere Therapeutics recently reported that the FDA has extended its review of the supplemental New Drug Application for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS) to a new ...
By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...
The FDA has issued a complete response letter for the partners’ application in EBV+PTLD, marking the agency’s second snub of ...
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...
MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.
Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...
The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...
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