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Datroway joins Trodelvy for frontline TNBC in the EU

AstraZeneca and Daiichi Sankyo's Datroway enters the first-line triple-negative breast cancer market in the EU, taking on Gilead's Trodelvy.

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Adcomm backs Replimune melanoma drug, despite data concern

Replimune's RP1 immunotherapy for melanoma clears advisory committee vote by 10 to three, despite FDA concerns about the design of the IGNYTE study.

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Cytokinetics' cardiomyopathy drug cleared for NHS use

Cytokinetics gets simultaneous MHRA and NICE approvals for hypertrophic cardiomyopathy (HCM) therapy Myqorzo.

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Lawmakers seek answers from RFK on Gardasil shot settlement

Four Democratic senators are investigating whether the family of HHS Secretary RFK Jr is profiting from what they assert are "bogus" vaccine lawsuits.

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FDA advisors vote no to Capricor's DMD therapy

FDA advisors voted that Capricor has not shown efficacy for deramiocel in Duchenne muscular dystrophy, due to altered endpoints in its main trial.

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EU first to clear AbbVie's Rinvoq for alopecia areata

AbbVie's fast-growing JAK inhibitor Rinvoq has been cleared for alopecia areata in the EU, its first market for the hair loss disorder.

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