FDA Beats PMDA and EMA on Oncology Approvals
FDA hands down beats other regulatory authorities in approving oncology drugs.
As first reported by Alec Gaffney
of the news arm of the Regulatory Affairs Professional Society, the FDA hands down beats other regulatory authorities in approving oncology drugs.
In his article, Gaffney reports on
FDA Commissioner’s Margaret Hamburg, MD, blog
on achievements at the FDA. The oncology approvals were only one highlight from a report issued by the Centre for Innovation in Regulatory Science. In that report, CIRS found that the median approval times for anti-cancer beats median approval times for anti-cancer drugs in days was 450 for the EMA, 365 for the PMDA and 240 for the FDA.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
