regulatory approval

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Pfizer's Tukysa greenlit for earlier use in breast cancer

Pfizer gets FDA approval for maintenance use of its oral HER2 inhibitor Tukysa in breast cancer, which it hopes will unlock renewed sales growth.

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A female palm containing a Rhapsido tablet

Rhapsido is first drug cleared for chronic hives disorder SD

Novartis' oral BTK inhibitor Rhapsido has had its label expanded in the US to include a second indication that causes chronic hives.

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Click claims FDA okay for first-in-class schizophrenia DTx

Click Therapeutics has won the first-ever FDA approval for a treatment for the negative symptoms of schizophrenia, a DTx called Motivista.

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Lilly's BTK drug Jaypirca joins first-line options in US

Lilly's noncovalent BTK inhibitor Jaypirca has been cleared by the FDA for its first frontline indication, but will it be reserved for later-line use?

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FDA clears first drug for MCT8 deficiency

Sweden's Egetis has won approval in the US for the first-ever treatment for people living with the ultra-rare genetic disease MCT8 deficiency.

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AbbVie's Cerevel takeover delivers Parkinson's approval

The first drug from AbbVie's $8.7 billion takeover of Cerevel two years ago, Parkinson's disease therapy Juvmo, has won FDA approval.

Pfizer's Tukysa greenlit for earlier use in breast cancer

Rhapsido is first drug cleared for chronic hives disorder SD

Click claims FDA okay for first-in-class schizophrenia DTx

Lilly's BTK drug Jaypirca joins first-line options in US

FDA clears first drug for MCT8 deficiency

AbbVie's Cerevel takeover delivers Parkinson's approval

Iambic prices its IPO, seeking to raise up to $160m

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regulatory approval

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