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A boxed warning has been added to the labeling for Prolia (denosumab) based on FDA review of information on the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease. Read More
CDRH set a new record last year, says its latest annual report, granting marketing authorization to 124 novel devices, excluding emergency use authorizations (EUAs), the highest in the more than 40-year history of the center. Read More
The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the company an untitled letter. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
High drug prices and barriers to generic drugs are the targets of Sens. Amy Klobuchar (D-Minn.) and Bernie Sanders (I-Vt.) who are seeking answers from pharmaceutical manufacturers. Read More
Senator Thom Tillis (R-N.C.) has warned the Biden Administration its invoking of a controversial policy framework that allows the government to access patents developed using federal funds will stop innovation in medicine and technology, not reduce prices. Read More
Building on the experience of other EU alliances that address major industrial challenges, the European Commission (EC) plans to bring together drugmakers, regulators, and civil representatives to address persistent drug shortages that have limited the supply of key medicines in the EU. Read More
In a decline from its 89 approvals in 2022, the European Medicines Agency (EMA) recommended marketing authorizations for 77 human drugs in 2023, including 39 new active substances, 17 orphan drugs, 14 generics, and eight biosimilars, according to the agency’s annual report. Read More
Brushing aside a pharmaceutical coalition’s First Amendment claims and upholding a 2023 advisory opinion, a federal judge has rejected a plan for a proposed cancer-drug price relief program, ruling that it runs afoul of the Anti Kick-Back Statute (AKS). Read More
Men taking valproate, a commonly prescribed antiepileptic, should be cautioned that the drug could increase the risk of neurodevelopmental disorders in their offspring by up to 50 percent compared to similar medications, according to the safety committee of the European Medicines Agency (EMA). Read More