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Importing prescription drugs to cut U.S. drug prices and improve access to medicines poses safety risks, the Council for Affordable Health Coverage (CAHC) argued, warning the FDA against expanded drug importation policies. Read More
Novartis subsidiary Sandoz abandoned its pursuit of U.S. approval for its biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) and said it plans to focus on other products in the biosimilar pipeline. Read More
FDA Commissioner Scott Gottlieb defended the FDA’s approval of a powerful opioid that critics say is more addictive and susceptible to diversion than fentanyl — and said the agency plans to consider the merits of any new drug along with efforts to address the opioid epidemic. Read More
The Congressional Diabetes Caucus called on policymakers to take steps designed to bring down insulin prices, including requiring insulin manufacturers and pharmacy benefit managers to disclose rebate details. Read More
After facing years of delays, HHS has put its foot down on a final rule establishing fines for drugmakers that knowingly overcharge “safety-net” healthcare providers. Read More
The FDA logged a steadily increasing number of fast-tracked ANDAs in fiscal year 2018, according to the agency’s first annual report mandated by the FDA Reauthorization Act. Read More
A joint FDA advisory committee Friday voted in favor of the effectiveness, safety and risk-benefit profile of Sage Therapeutics’ NDA for the treatment of post-partum depression. Read More
The petition comes on the heels of a decision by the Eighth Circuit Court of Appeals, which declared that Act 900 was partially preempted by the Medicaid Part D and Employee Retirement Income Security Act of 1974 (ERISA). Read More