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Gottlieb joins Pfizer board, a few weeks after quitting FDA

Former FDA commissioner Scott Gottlieb has stoked controversy after being appointed to Pfizer’s board of directors, just a few weeks after leaving his government post.

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Roche's blockbuster breast cancer drug Herceptin

FDA approves Herceptin biosimilar as US patent expires

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry.

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Catalyst squares up to FDA over rival drug approval

Catalyst Pharma is suing the FDA over its approval of a potential rival to its rare disease therapy Firdapse, calling it “arbitrary, capricious, and contrary to law.”

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Motif pummelled as FDA asks for more data on antibiotic

Shares in UK biotech Motif Bio fell more than 50% after its much-delayed antibiotic was held up at the FDA once again by a request for another clinical trial.

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FDA rejects Heron's non-opioid painkiller

Shares in US biotech Heron Therapeutics were sharply down yesterday after the FDA rejected its post-operative painkiller, saying additional manufacturing and non-clinical information is nee

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