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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The Department of Health and Human Services (HHS) has withdrawn a controversial and unpopular Trump-era final rule that would have required federal health agencies to reassess their regulations every 10 years or face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
Teva Pharmaceuticals and Allergan will pay more than $161 million to the state of West Virginia to settle allegations that the companies contributed to the opioid epidemic. Read More
Sens. Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) introduced a bill this week that directs the Federal Trade Commission (FTC) to hold pharmacy benefit managers (PBM) accountable for allegedly deceptive pricing practices that raise the costs of prescription drugs. Read More
In an effort to get more gonadotropin-releasing hormone (GnRH) analogues to market for advanced prostate cancer patients, the FDA has published final guidance with recommendations spanning the full spectrum of development, including clinical trial design. Read More
Oncology research and drug development continue to surge globally, with 159 new medications launched since 2012 — and a record 30 of those in 2021 — according to the life science research analytics firm IQVIA Institute. Read More
“We are holding pharmaceutical companies accountable and working with them to offer more affordable medication,” said New York State Senate Majority Leader Andrea Stewart-Cousins (D). Read More