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The approval follows the recommendation of Polivy for this indication from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Read More
The Senate’s bill to reauthorize FDA user fee programs for drugs, biologics and medical devices, introduced last week by Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (N.C.), includes proposed reforms of the FDA’s accelerated approval program, a subject the House declined to address in its version of the user fee program reauthorization. Read More
A bipartisan pair of senators — Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) — are pressing federal agencies to close oversight gaps that delay generic drugs and in turn keep drug prices high. Read More
The Department of Health and Human Services (HHS) has withdrawn a controversial and unpopular Trump-era final rule that would have required federal health agencies to reassess their regulations every 10 years or face eliminating those rules. Read More