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FDA approves Genentech’s Ocrevus for relapsing and primary progressive forms of MS
cphi-online
March 31, 2017
An important new treatment option for people with relapsing forms of multiple sclerosis demonstrating superior efficacy on the three major markers of disease activity compared with Rebif.
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FDA: Helping Small Businesses Get Big Results
FDA
March 31, 2017
It is well known that small business is vital to the success of the American economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
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FDA in India – Championing a Culture of Quality
FDA
March 30, 2017
One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States.
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FDA Grants Priority Review for Eagle Pharmaceuticals’ Ryanodex NDA for the Treatment of Exertional H
americanpharmaceuticalreview
March 28, 2017
Ryanodex NDA (dantrolene sodium) for the treatment of exertional heat stroke (EHS) has been accepted for filing and granted a priority review designation by the U.S. Food and Drug Administration (FDA).
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Merck and Pfizer secure US FDA approval for Bavencio to treat skin cancer
pharmaceutical-technology
March 28, 2017
Merck’s biopharmaceutical business EMD Serono and Pfizer have obtained the US Food and Drug Administration’s (FDA) approval for a 20mg/mL Bavencio (avelumab) injection to treat ...
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FDA approves Parkinson's disease drug
cphi-online
March 27, 2017
First NCE approved for PD patients with motor fluctuations in the US in more than a decade.
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FDA Grants Breakthrough Therapy Designation for Rituxan®in Pemphigus Vulgaris
americanpharmaceuticalreview
March 27, 2017
Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Rituxan® (rituximab) for pemphigus vulgaris...
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FDA approves first treatment for rare form of skin cancer
worldpharmanews
March 27, 2017
The U.S. Food and Drug Administration has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior ch
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US FDA grants Fast Track designation for Shire’s SHP655
pharmaceutical-technology
March 24, 2017
The US Food and Drug Administration (FDA) has granted Fast Track designation for Shire’s recombinant ADAMTS13 (SHP655 or previously known as BAX930) to treat acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP).
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Clobetasol propionate is used for treating various skin disorders including eczema and psoriasis.
biospectrumasia
March 24, 2017
The United States Food and Drug Administration (USFDA) has given its nod for Clobetasol Propionate Ointment, used for the treatment of various skin conditions.