Recalls reported by FDA for OTC drugs, nutritionals and personal care products.
DRUG-CLASS III
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.
A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.
Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.
Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.
