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An FDA advisory committee unanimously backed FDA approval of Valeant’s Siliq to treat plaque psoriasis, but was split on the risk management of the candidate due to reported suicides. Read More
The UK’s drug pricing watchdog has recommended that the National Health Service reimburse for Amgen’s melanoma therapy Imlygic, provided that the company lowers the price. Read More
The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More
The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More
The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions. Read More