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AstraZeneca lung cancer drug receives FDA approval europeanpharmaceuticalreview
April 05, 2017
The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets...
FDA approves first-ever atopic dermatitis biologic treatment pharmafile
April 01, 2017
Sanofi and Regeneron’s Dupixent (dupilumab) has become the first biologic medicine to be approved by the FDA for the treatment of moderate-to-severe atopic dermatitis (AD), the most common form of eczema, in adults when topical prescription therapies are
Trump's FDA pick vows to sever past pharma ties to avoid partisanship pharmafile
March 31, 2017
Donald Trump recently announced his top pick for Commissioner of the FDA as Dr Scott Gottlieb,Gottlieb has voiced plans to sever these connections to avoid any potential conflict of interest.
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.
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.
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.
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).
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 ...
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.
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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