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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
