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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found that certain cancer medicines that contain ifosfamide, an injectable chemotherapy drug, pose higher risks of brain damage in solution form than in powder form. Read More
Connecticut-based online pharmacy Valisure has petitioned the FDA to recall specific batches of the type 2 diabetes drug metformin from numerous manufacturers because it found high levels of N-Nitrosodimethylamine (NDMA) in the products. Read More
The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling. Read More
Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs. Read More
The Institute for Clinical and Economic Review (ICER) has questioned the cost-effectiveness of Novo Nordisk’s recently approved Type 2 diabetes treatment Rybelsus (oral semaglutide) compared to alternatives. Read More
GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects. Read More