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The European Medicines Agency (EMA) has endorsed an International Council for Harmonization (ICH) guideline on testing to determine whether pharmaceuticals contain cancer-causing agents. Read More
In a preliminary opinion, the European Commission told Teva Pharmaceuticals that it suspects the Israeli drugmaker breached EU antitrust law by engaging in anticompetitive practices to delay competition for its blockbuster multiple sclerosis (MS) drug Copaxone (glatiramer). Read More
Senate Republicans have introduced a bill to roll back measures in the Inflation Reduction Act that permit Medicare to negotiate drug prices and cap annual drug expenses for seniors at $2,000 a year. Read More
In the latest move in a multi-year wrangle between the FDA and Vanda Pharmaceuticals over the agency’s proposed refusal to approve a supplemental new drug application (sNDA) for Hetlioz (tasimelteon) as a treatment for jet lag, the FDA is offering Vanda a hearing — but only under specified conditions. Read More
The FDA wants to remove Covis Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate) from the market, contending that 11 years of postmarket data have failed to show Makena actually does what Covis claims — improve neonatal outcomes in premature births. Read More
Congress may have delayed reauthorization of the FDA’s user fee programs until almost the last hour, but the agency had its table of rates worked out and queued up for publication within the week. Read More