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FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma drugs.com
May 10, 2017
The U.S. Food and Drug Administration granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma...
US FDA makes eight observations at Lupin’s Aurangabad unit financialexpress
May 10, 2017
The inspection was completed on April 26, 2017
CartiHeal raises $ 18.3 Million biospectrumasia
May 10, 2017
The Israeli company CartiHeal is preparing for a human clinical trial of Agili-C, its implant for regenerating damaged cartilage and bone.
FDA approves drug to treat ALS worldpharmanews
May 08, 2017
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease.
Regulus CEO heads to exit as company struggles with FDA hold pharmafile
May 08, 2017
Regulus seemed to be in a good place just last year as its lead drug candidate performed well in a Phase ...
Sangamo Therapeutics Announces Special Regulatory Designations from the FDA americanpharmaceuticalreview
May 05, 2017
Sangamo Therapeutics announced it has received special regulatory designations for three of the company’s clinical programs from the U.S. Food and Drug Administration (FDA).
FDA approves new combination treatment for acute myeloid leukaemia europeanpharmaceuticalreview
May 05, 2017
The US Food and Drug Administration (FDA) has approved Novartis’ Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy
AlzProtect : The American Food and Drug Administration (FDA) Has Granted AZP2006 the Orphan Drug Des contractpharma
May 05, 2017
The drug candidate AZP2006 has an original mechanism of action and aims to treat several neurodegenerative pathologies for which there is no treatment: Tauopathies including Alzheimer's disease and Progressive Supranuclear Palsy (PSP).
AstraZeneca’s Imfinzi receives FDA-accelerated approval for urothelial cancer pharmaceutical-technology
May 04, 2017
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) ...
Soligenix Receives FDA Protocol Clearance of Phase 3 Clinical Trial of SGX942 americanpharmaceuticalreview
May 04, 2017
Soligenix announced it received US Food and Drug Administration (FDA) clearance to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer (HNC) patients being treated with chemor

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