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US Food and Drug Administration
Biosimilar trends in 2016
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US FDA warns of serious data integrity violations at DRL
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Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by FDA
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US FDA approves ipilimumab
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Sandoz launches Zarxio, the first biosimilar in US
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Sun Pharma, Wockhardt recall drugs from US market
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US FDA approves Repatha to treat certain patients with high cholesterol
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Aurobindo gets US FDA nod for hepatitis B drug
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US FDA approves Sun Pharma’s Ximino capsules
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Wockhardt recalls 12 drugs in US made at two India units
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