regulatory approval

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Ahead of ASCO data drop, AZ gets key Imfinzi approval

AstraZeneca has claimed another key FDA approval for Imfinzi in bladder cancer, as an add-on to BCG therapy for early non-muscle invasive disease.

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AbbVie's Immunogen buy delivers rare cancer drug approval

AbbVie's Decnupaz approval will give patients with rare blood cancer BPDCN an alternative to Stemline's Elzonris with a simpler dosing regimen.

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Datroway is first TROP2 drug for frontline breast cancer

AZ and Daiichi's Datroway has been cleared by the FDA as first-line treatment for triple-negative breast cancer patients ineligible for immunotherapy.

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Gilead claims first FDA nod for a hepatitis D therapy

At its second attempt, Gilead has won FDA approval for chronic hepatitis D virus drug Hepcludex, four years after it was cleared in the EU.

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AZ gets first okay for new hypertension drug baxdrostat

AstraZeneca is the first company to get FDA approval for an aldosterone synthase inhibitor for hypertension, ahead of rival Mineralys.

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FDA hands BeOne, Taiho approvals for blood cancers

BeOne gets the nod for BCL2 inhibitor Beqalzi in mantle cell lymphoma, while Taiho's Inqovi has acute myeloid leukaemia added to its label.

Ahead of ASCO data drop, AZ gets key Imfinzi approval

AbbVie's Immunogen buy delivers rare cancer drug approval

Datroway is first TROP2 drug for frontline breast cancer

Gilead claims first FDA nod for a hepatitis D therapy

AZ gets first okay for new hypertension drug baxdrostat

FDA hands BeOne, Taiho approvals for blood cancers

ASCO 2026: First to first line in HER-2 NSCLC, with Itziar C...

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regulatory approval

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