regulatory approval

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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.

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GSK ends decades-long hiatus in oral antibiotics for UTIs

The FDA has approved GSK's Blujepa, the first new-mechanism oral antibiotic for uncomplicated UTIs in nearly 30 years, after a priority review.

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

GSK ends decades-long hiatus in oral antibiotics for UTIs

GBL joins CVC in €10.7bn takeover bid for Recordati

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

regulatory approval

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