regulatory approval

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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.

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Boy in wheelchair, only lower half of his body visible

Novartis' SMA gene therapy cleared for wider use in US

A new FDA approval means Novartis now has a gene therapy option for almost everyone with spinal muscular atrophy (SMA), regardless of their age.

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Bayer takes on Boehringer with FDA nod for lung cancer drug

Bayer joins Boehringer with FDA approval for a second-line, oral therapy for HER2-positive lung cancer, setting up a marketing battle in the US.

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

Novartis' SMA gene therapy cleared for wider use in US

Bayer takes on Boehringer with FDA nod for lung cancer drug

Novo Nordisk fight with KBP Bio will go to arbitration

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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