regulatory approval

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FDA resurrects Satsuma's nasal migraine treatment

More than a year after it was rejected by the FDA, Satsuma Pharma's intranasal migraine therapy Atzumi has been given the go-ahead by the agency.

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J&J's 'Swiss army knife' drug gets first FDA approval

Johnson & Johnson has its first regulatory approval for FcRn blocker Imaavy, getting a green light in the US for generalised myasthenia gravis (gMG).

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Abeona prices rare cell disorder gene therapy at $3.1m

Abeona Therapeutics' Zevaskyn has been approved in the US as a treatment for the rare skin disorder recessive dystrophic epidermolysis bullosa (DEB).

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Dr Yu Xia, founder, chairwoman, president and chief executive of Akeso

Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Akeso has bagged an FDA approval for its PD-1 inhibitor penpulimab and reported new data on highly-touted PD-1/VEGF bispecific ivonescimab.

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Roche gets EU okay for chest pain algorithm

Roche has claimed a CE Mark in the EU for an AI algorithm that can help doctors decide whether patients with chest pain are having a heart attack.

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FDA clears first migraine DTx from Click Therapeutics

Click Therapeutics' digital therapeutic (DTx) for migraine prevention has been cleared by the FDA, becoming the first treatment of its type in the US.

FDA resurrects Satsuma's nasal migraine treatment

J&J's 'Swiss army knife' drug gets first FDA approval

Abeona prices rare cell disorder gene therapy at $3.1m

Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Roche gets EU okay for chest pain algorithm

FDA clears first migraine DTx from Click Therapeutics

Praxis soars on rare childhood epilepsy trial data

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regulatory approval

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