regulatory approval

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AZ, Daiichi get EU okay for breast cancer drug Datroway

AstraZeneca and Daiichi Sankyo have claimed approval from the European Commission for Datroway, their TROP2-directed ADC for breast cancer.

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AZ grabs pair of EU approvals for top cancer drugs

AstraZeneca is celebrating two approvals for cancer drugs Imfinzi and Enhertu in the EU as it faces increased competition to its top-seller Tagrisso.

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Uplizna is first drug FDA-cleared for rare disease IgG4-RD

Amgen has bagged a second indication for its B cell-depleting therapy Uplizna after the FDA cleared it for rare inflammatory disease IgG4-RD.

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Novartis gets FDA nod for second of three IgAN drugs

Novartis has claimed accelerated approval in the US for Vanrafia, one of a trio of drugs it hopes will revolutionise the treatment of IgA nephropathy.

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UK first to approve Rotop's prostate cancer imaging agent

The UK has given a world-first approval to Rotop's RoTecPSMA, a new imaging agent for detecting lesions in men with prostate cancer.

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FDA clears first treatment for Prader-Willi syndrome

Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for excessive eating in rare disorder Prader-Willi syndrome.

AZ, Daiichi get EU okay for breast cancer drug Datroway

AZ grabs pair of EU approvals for top cancer drugs

Uplizna is first drug FDA-cleared for rare disease IgG4-RD

Novartis gets FDA nod for second of three IgAN drugs

UK first to approve Rotop's prostate cancer imaging agent

FDA clears first treatment for Prader-Willi syndrome

Consolidating data strategy for global success: Insights fro...

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regulatory approval

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