regulatory approval

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AZ gets sought-after lung cancer approval for Tagrisso

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targete

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Second Niemann-Pick approval brings more hope to patients

In the space of four days, the number of FDA-approved therapies for ultra-rare genetic disorder Niemann-Pick disease has gone from zero to two, transforming the prospects for patients.

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traditional red and black painted bamboo walkway in Japan

Lilly gets second approval, in Japan, for Alzheimer's drug

Eli Lilly has opened up a second market for its new Alzheimer's disease therapy Kisunla, after Japan followed the US in approving the drug.

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Ipsen crosses EU finish line with Alagille syndrome drug

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagill

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Sanofi's Sarclisa gets one up on rival Darzalex in myeloma

Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight.

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