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FDA requests removal of certain prescription opioid for risks related to abuse
cphi-online
June 12, 2017
Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatit.is C
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FDA Approves Two-Month Aristada for Treatment of Schizophrenia
drugs.com
June 08, 2017
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
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FDA Approves Zerviate
drugs.com
June 08, 2017
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
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OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters
en-cphi.cn
June 07, 2017
Announcement marks company's official entry into the US market
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BioPharma Services Completes 3 FDA Inspections
contractpharma
June 07, 2017
BioPharma Services has completed 3 inspections this month by the U.S. FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, MO.
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FDA Approves Zerviate
drugs.com
June 07, 2017
Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24%
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Sun Pharma announces US FDA Filing acceptance of BLA
pharmaasia
June 07, 2017
Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis.
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FDA approves Roche’s lung cancer companion diagnostic
europeanpharmaceuticalreview
June 07, 2017
The US Food and Drug Administration (FDA) have approved Roche’s VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible ...
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BioPharma Services Completes 3 FDA Inspections
contractpharma
June 06, 2017
BioPharma Services has completed 3 inspections this month by the U.S. FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, MO.
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Zydus Cadila gets US FDA nod for anti depressant
expressbpd
June 06, 2017
Zydus Cadila has received the US health regulator’s nod to market Mirtazapine orally disintegrating tablets, an anti depressant, in the US market.