News FDA hands another rejection to Replimune's melanoma therapy Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.
News FDA knocks back Biogen's high-dose Spinraza Biogen's efforts to defend its SMA business have been dealt a setback after the FDA declined to approve a high-dose version of Spinraza.
News Replimune receives CRL on BLA for RP1 for advanced melanoma Replimune has announced the FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 combined with nivolumab.
News Chiesi signs $1.9bn deal to buy KalVista and its HAE drug Chiesi has boosted its rare disease business with an agreement to buy KalVista and Ekterly, its oral drug for treating attacks in rare disease HAE.
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