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EC grants approval to BMS' Opdivo combo for gastroesophageal cancer pharmaceutical-technology.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceutical-technology.com Daily Mail and Mail on Sunday newspapers.
EU approves Opdivo plus Yervoy for colorectal cancer europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.
EC green light for Opdivo plus Yervoy in metastatic colorectal cancer pharmatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmatimes.com Daily Mail and Mail on Sunday newspapers.
Sarah Silbiger via Getty Images A group of advisers to the Food and Drug Administration this week recommended the agency maintain four of six recent cancer immunotherapy approvals despite a lack of evidence the medicines help patients live longer. The positive votes, which took place over an unusual three-day meeting, could push the FDA to keep drugs from Roche, Bristol Myers Squibb and Merck & Co. on the market while the companies complete additional studies to confirm their benefit. The FDA typically, though not always, follows the advice of its advisory committees. If the FDA does adhere to the panel votes, regulators could fuel further criticism that the agency isn t holding drugmakers to the terms of the accelerated approval pathway it s used to make new cancer drugs available quickly. ....