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FDA makes unprecedented move, asks Endo to pull painkiller from market
pharmaphorum
June 12, 2017
The FDA has asked Endo to voluntarily remove its painkiller Opana ER from the US market, because of concerns it is fuelling the country’s opioid addiction epidemic.
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SHP465 back in front of the FDA and data for Venclexta
epvantage
June 12, 2017
SHP465 back in front of the FDA and data for Venclexta
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FDA’s move could mean Endo suffers from opioid withdrawal
epvantage
June 12, 2017
FDA’s move means that Endo suffers from opioid withdrawal
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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.