#marketingapplication
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pharmaphorum.bsky.social
The #FDA has started a review of the #marketingapplication for #Takeda's #TYK2inhibitor zasocitinib in #psoriasis, setting up a decision in mid-March 2027.

pharmaphorum.com/news/fda-dec...
FDA to decide on Takeda's psoriasis blockbuster hope in Q1
The FDA has started a review of the marketing application for Takeda's TYK2 inhibitor zasocitinib in psoriasis, setting up a decision in mid-March.
pharmaphorum.com
September 15, 2026 at 10:24 AM
pharmaphorum.bsky.social
#uniQure has agreed with the #FDA that it can proceed with a #marketingapplication for #Huntingtons disease #genetherapy AMT-130, using data that it already has on hand, rather than running another trial.
uniQure sets course to US filing for Huntington gene therapy
Shares in uniQure have rocketed this morning, as it emerges that the FDA will not require it to run a new trial of Huntington's gene therapy AMT-130.
buff.ly
June 17, 2026 at 3:30 PM
pharmaphorum.bsky.social
#Moderna confirmed this morning that the #FDA has had a change of heart on the #marketingapplication for its #influenzavaccine mRNA-1010, and will now start a #review.

pharmaphorum.com/news/fda-rel...
FDA relents and will review Moderna's flu shot
The FDA will start a review of Moderna's flu jab mRNA-1010, after refusing to accept the filing last week, with a new "regulatory approach."
pharmaphorum.com
February 18, 2026 at 4:21 PM