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Zydus Cadila gets US FDA nod to market anti-obesity drug
financialexpress
July 03, 2017
The drug will be produced at the group’s formulations manufacturing facility at Moraiya in Ahmedabad
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Rise in product recalls prompts FDA to warn of possible BCC contamination
europeanpharmaceuticalreview
July 03, 2017
The US Food and Drug Administration (FDA) has advised manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC) contamination.
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Data Analysis of Relevant Warning Letters of FDA on Computer System
en-cphi.cn
June 30, 2017
As is known to all, FDA, one of the strictest drug administration agencies in the world, mainly take charge of safeguarding the health and safety of consumers based on federal food, drug, cosmetics laws and other laws.
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FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder
firstwordpharma
June 30, 2017
FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder
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FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer
firstwordpharma
June 30, 2017
FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer
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FDA creates team to tackle backlog of orphan drug designation requests
firstwordpharma
June 30, 2017
FDA creates team to tackle backlog of orphan drug designation requests
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FDA Grants Priority Review of 10 mg XARELTO to Reduce VTE Risk
americanpharmaceuticalreview
June 29, 2017
Janssen Research & Development announced the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of VTE after at
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FDA grants fast track designation to Synlogic’s SYNB1020 synthetic biotic treatment
pharmaceutical-technology
June 29, 2017
Synlogic has received fast track designation for its lead product candidate SYNB1020 from the US Food and Drug Administration (FDA).
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US FDA approves Natco’s ANDA for generic version of Vidaza
expressbpd
June 29, 2017
Natco and Breckenridge Pharmaceutical plan to launch the product in the US market
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FDA tackles drug competition to improve patient access
worldpharmanews
June 29, 2017
Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.