The FDA has granted Accelerated Approval (AA) to Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria (high levels of protein in the urine) in adults at risk of rapid progression of…
Reacting to concerns about good clinical practice at sites run by one of its trial contractors — Boston-based Care Access — Pfizer announced it will drop Care Access sites from…
Despite continuing pandemic conditions, the FDA’s Office of Pharmaceutical Quality (OPQ) was able to conduct 65 on-site pre-license inspections in 18 countries in 2022 — up from 47 in 2021…
More than one-fifth of the new drugs approved by the FDA from 2017 through 2020 were either refused marketing authorization or not recommended for reimbursement in Australia, Canada, or the…
Will the Pharmaceutical Research and Manufacturers of America (PhRMA) start losing more members this year in the wake of the powerful lobbying group’s inability to stop the 2022 Inflation Reduction…
Madrigal Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug resmetirom might be a cost-effective treatment for the disease if priced at no more than $12,820 per year, according to a draft cost-benefit analysis…
Members of the Senate Commerce Committee heard testimony yesterday from panelists mostly in favor of a recently reintroduced bill that would compel pharmacy benefit managers (PBM) to be transparent about…
Multiple drugmakers have filed amicus briefs to the U.S. Supreme Court refuting a broad patent claim by Amgen that — if upheld — could have sweeping implications in drug development.…
In a unanimous vote of 15-0, members of two FDA advisory committees agreed that the benefits of over-the-counter (OTC) intranasal naloxone far exceed any risks the long-approved drug might carry.…
In response to President Biden’s call for drug price-lowering demonstration projects, HHS has proposed three pilot programs designed to make therapeutics more affordable for Medicare and Medicaid beneficiaries. Source: Drug…