Complete Response Letter for sBLA for Keytruda in high-risk early-stage triple-negative breast cancer (TNBC) – Merck Inc.

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Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy – Roche

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EU approves SC version of Tysabri for multiple sclerosis – Biogen

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FDA approval of additional indication for Vyxeos for the treatment of secondary acute myeloid leukemia in pediatric patients – Jazz Pharma

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New real-world observational analysis of Uptravi underscores the importance of risk assessment for treating pulmonary arterial hypertension patients -Johnson & Johnson

Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension (PAH) patients treated with Uptravi (selexipag)from Johnson & Johnson, either maintained (56%) or reduced (20%) their one-year mortality risk score. The SPHERE results were published in the April issue of the Journal […]

FDA approves Qelbree for attention-deficit hyperactivity disorder in pediatric patients – Supernus Pharmaceuticals

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AZD 1222 US phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis – AstraZeneca

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FDA approves Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes – Zealand Pharma

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CHMP recommends expanded approval for Saxenda in obesity – Novo Nordisk

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EMA validates MAA for Trodelvy under accelerated review in triple-negative breast cancer – Gilead Sciences

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