In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are ...
Chen: Yes, obesity is experiencing accelerated growth over the last couple of years. According to our sister product Evaluate ...
AI-driven discovery, EHR-based real-world evidence, and synthetic patient modeling are rapidly reshaping drug repurposing, reducing development timelines, expanding therapeutic applications, and ...
In today’s ACT Brief, we look at new insights on strategy-driven clinical development, fresh survey data revealing persistent ...
For industry-sponsored trials in autoimmune inflammation therapeutic areas, the dominating indications include atopic ...
Examine the rise of personalized and biomarker-driven therapies, the logistical challenges of rare patient populations, and ...
The FDA has launched a secure, GovCloud-based agentic AI system to support regulatory workflows across review divisions, ...
Former FDA Commissioners Warn New Vaccine Policies Could Undermine Longstanding Regulatory Framework
In their NEJM commentary, the former FDA heads stated, “We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ...
In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...
In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the ...
The FDA has granted accelerated approval to Otsuka’s Voyxact for adults with primary IgAN at risk of disease progression, ...
In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...
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