regulatory approval

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AZ first to AKT finish line, but FDA clears narrow label

AstraZeneca has claimed FDA approval for its first-in-class pan-AKT inhibitor capivasertib, getting a green light for the drug as a treatment for breast cancer, but with a

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UK first to approve Vertex, CRISPR drug for blood disorders

The first-ever CRISPR-based gene-editing therapy has been approved for marketing in the UK for inherited blood disorders sickle cell disease (SCD) and transfusion-dependen

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Takeda gets okay in US for rare blood disorder drug

Patients in the US with ultra-rare blood clotting disorder congenital thrombotic thrombocytopenic purpura (cTTP) have an FDA-approved therapy for the first time, after Tak

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First chikungunya vaccine approved by FDA

Valneva has claimed the accolade of becoming the first drugmaker to win FDA approval for a vaccine for chikungunya virus, a potentially life-threatening mosquito-borne dis

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Takeda bags FDA okay for Fruzaqla in colorectal cancer

The FDA has approved Takeda’s Fruzaqla for a group of patients with relapsed or refractory metastatic colorectal cancer, offering another option for patients who have exha

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Lilly gets FDA okay for tirzepatide as obesity therapy

Novo Nordisk is finally facing some major competition to its obesity franchise juggernaut, now that Eli Lilly’s rival therapy tirzepatide has been approved by the FDA as a

AZ first to AKT finish line, but FDA clears narrow label

UK first to approve Vertex, CRISPR drug for blood disorders

Takeda gets okay in US for rare blood disorder drug

First chikungunya vaccine approved by FDA

Takeda bags FDA okay for Fruzaqla in colorectal cancer

Lilly gets FDA okay for tirzepatide as obesity therapy

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regulatory approval

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