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FDA Accepts BioCryst Orladeyo NDA

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FDA accepts a BioCryst NDA for Orladeyo to be used in pediatric patients with hereditary angioedema.

Positive Data on Keytruda in Ovarian Cancer: Merck

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Merck's Keytruda meets a Phase 3 clinical trial primary endpoint of progression-free survival for treating patients with platinum-...

FDA OKs Incytes Zynyz for Anal Cancer

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FDA approves an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel for the first...

Troriluzole PDUFA Action Date Extended

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FDA says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.

FDA Initiatives Help Early-Phase Cancer Trials: Post

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IQVIA senior director David Cameron says FDA oncology initiatives like Project FrontRunner can help speed innovative cancer treatm...

Roche Companion Diagnostic for AbbVies Emrelis OKd

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FDA approves Roches Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET protein expression in lung can...

Nipro Renal Recalls MedicaLyte Hemodialysis Product

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Nipro Renal Soultions recalls (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate due to the potential for the presence of vis...

Agency Has Evolved in the Last 10 Years: Verdun

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CBERs Nicole Verdun tells a Friends of Cancer Research meeting on next-generation therapies that FDA has evolved in the last decad...

Makary Says Vaccine Framework Coming Soon

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FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help wi...

CGMP Violations at Chinas Shantou S.E.Z. Baojie

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FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be re...