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CDER released final guidance on Thursday on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Read More
Amgen’s five-year legal challenge against Sanofi and Regeneron’s competitor for its cholesterol-lowering drug Repatha (evolocumab) is set to continue next month in a Delaware federal court. Read More
The FDA issued a warning letter to Ecometics for serious GMP violations at its Norwalk, Conn., facility, including making drugs on equipment used to make toxic non-drug products. Read More
Testerone level should be used as a surrogate endpoint in phase 3 trials of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer, the FDA says in a new draft guidance. Read More
The bill requires drugmakers to submit reports to HHS no later than 30 days prior to increasing the price of a non-rare disease, non-vaccine drug that costs $100 or more per month or course of treatment. Read More
Rep. Mike Kelly (R-Pa.) has asked acting FDA Commissioner Ned Sharpless on why the FDA doesn’t consider insulin to be a complex generic drug — a change that would help boost competion and lower prices. Read More