News Amgen baulks at FDA request to withdraw Tavneos Amgen confirmed on its fourth-quarter results call that it has resisted a request to pull Tavneos for ANCA-associated vasculitis from the US market.
News EMA looks into 'data integrity' issue with Amgen's Tavneos Concerns about efficacy data in the main trial behind the approvals of Amgen and CSL Vifor's Tavneos have triggered a review in the EU.
R&D Cassava’s Alzheimer’s drug nears P3 readout, but SEC scandal... Cassava is advancing simufilam through a pivotal phase 3 trial, despite lingering controversy from a SEC investigation.
R&D Challenges and opportunities in synthetic clinical trials Of the many changes coming to clinical trials, one of the biggest potential paradigm shifts on the horizon is the elimination of placebo groups in some trials in favour of synthetic control
Digital Transitioning PROs from paper to digital: Maintaining data i... Patient-reported outcomes (PROs) provide important insights for clinical trials.
News Moderna builds commercial muscle as new launches loom Moderna expands its commercial team, as FDA issues a mostly positive briefing document on its seasonal flu shot, due to face an adcomm tomorrow.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.