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Teligent, Edge Pharma yank meds on superpotency, sterility concerns

Sterility concerns and out-of-spec testing results are two common sources of drug recalls. Now, the problems have hit two drugmakers at once. For one of …

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AbbVie’s Rinvoq, Pfizer’s Xeljanz and Lilly’s Olumiant slapped with new FDA warnings amid JAK safety crackdown

The second regulatory shoe has finally dropped for AbbVie, Pfizer and Eli Lilly amid the safety review of JAK inhibitors for inflammatory diseases. But confirmed …

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Autoimmune Diseases

Bristol Myers Squibb’s next-gen autoimmune med starts high-stakes FDA review amid classwide JAK scrutiny

After the FDA slapped an updated safety warning on marketed oral JAK inhibitors for inflammatory diseases, market watchers have started worrying about other candidates in …

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drug recall

Sagent Pharmaceuticals recalls injectable seizure med thanks to familiar packaging glitch

A familiar packaging snafu has led to another recall at Nichi-Iko Group’s Sagent Pharmaceuticals. The Illinois-based manufacturer is recalling four lots of injectable levetiracetam, which …

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