Over the past week, the FDA issued final guidance on drug security at the package level and announced a meeting of the medical imaging drugs advisory committee. Source: Drug Industry…

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…

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…

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…

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…

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…

A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s…

Looking back at FY 2023, CDER’s Office of Compliance’s recently issued annual report shows the office issued 170 human drug warning letters and classified 264 recalls affecting 1,178 drugs. Source:…

Vertex announced FDA approval of Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. Source: Drug Industry…

After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its…