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FDA clears first gene therapy for rare genetic disease WAS

Fondazione Telethon's Waskyra has become the first gene therapy in the US for Wiskott-Aldrich syndrome, and the first taken to market by a non-profit.

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BMS's Breyanzi is first CAR-T for marginal zone lymphoma

Bristol Myers Squibb has taken CAR-T therapy into new territory, after getting FDA approval for Breyanzi in marginal zone lymphoma.

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Lilly gets approval for earlier use of Jaypirca in CLL

Eli Lilly's fast-growing Jaypirca has won a new FDA approval as an earlier treatment for relapsed/refractory chronic lymphocytic leukaemia.

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J&J gets EU approval for Imaavy in gMG

J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.

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Innovent gets OK for China's first home-grown IL-23p19 drug

Innovent has picked up approval in China for Pecondle, its anti-IL-23p19 antibody, as a treatment for moderate-to-severe plaque psoriasis.

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Otsuka joins IgAN market with Voyxact approval in US

Otsuka has claimed FDA approval for its IgAN therapy Voyxact, joining an increasingly crowded market and beating rival Vera Therapeutics to the punch.

FDA clears first gene therapy for rare genetic disease WAS

BMS's Breyanzi is first CAR-T for marginal zone lymphoma

Lilly gets approval for earlier use of Jaypirca in CLL

J&J gets EU approval for Imaavy in gMG

Innovent gets OK for China's first home-grown IL-23p19 drug

Otsuka joins IgAN market with Voyxact approval in US

Are Makary's priority review vouchers about to be canned?

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regulatory approval

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