Medications

High court ruling speeds up generic biotech drug approval

The Supreme Court is speeding up the time for generic biotech drugs to become available to the public. The court's unanimous ruling Monday means a loss of billions in sales to makers of original versions.

Medical research

Assessing the impact of fast-track drug approval programs

Over the past decade, regulatory agencies such as the Federal Drug Administration (FDA) in the United States and the and the European Medicines Agency (EMA) in the European Union have put programs in place to get new drugs ...

Medications

Sen. Joe Manchin seeks to block new painkiller

U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse.

Medications

Adaptive pathways: EMA still leaves open questions unanswered

At the beginning of August, the European Medicines Agency (EMA) published a report on a pilot project of a new accelerated path for drug approval (adaptive pathways). In this approval procedure, for a highly restricted population ...

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