FDA and the sponsors of erythropoiesis-stimulating agents were mostly able to reach an agreement on safety revisions to labeling of the anemia therapies, but the agency was forced to employ its new regulatory authority to resolve a couple points of continued disagreement
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Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
