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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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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EMA validates MAA for relugolix for the treatment of advanced prostate cancer – Myovant Sciences

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CHMP issues advice on the use of Celltrion’s regdanvimab (CT-P59) for COVID-19 patients in the European Union

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FDA approves supplemental NDA for Exparel for postsurgical local analgesia in pediatric patients – Pacira BioSciences

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Insulet’s Omnipod 5 automated insulin delivery system improves clinical outcomes in type 1 diabetes

Insulet Corporation (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced positive results from the first pivotal trial for the Omnipod 5 Automated Insulin Delivery System. Omnipod 5, the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range […]