regulatory approval

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Rinvoq cleared for giant cell arteritis in EU, ahead of US

AbbVie has picked up another indication for its JAK inhibitor Rinvoq in the EU, becoming the first approved oral therapy for giant cell arteritis.

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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.

Rinvoq cleared for giant cell arteritis in EU, ahead of US

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

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

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regulatory approval

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