PharmExec7d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
JD Supra15d
FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law ...
pharmaphorum3d
A new fast track for NHS access - good news for niche innovators
This accelerated pathway for new drugs and therapies ... Intelligence and learnings from the delivery of the early and managed patient access schemes will be used to better understand impact ...
The American Journal of Managed Care23d
Price Caps During Accelerated Approval Would Help Address Financial Toxicity for Patients, Jensen Says
addressed challenges with the current accelerated approval pathway, which was created in 1992 to offer patients a way to gain access to novel therapies ahead of final results of a phase 3 trial.
Dyne: Accelerated Approval Of DYNE-101 Might Be Possible With Surrogate Biomarker
Dyne Therapeutics’ DYNE-101 shows positive results in phase 1/2 ACHIEVE study. Read why DYN stock may rise with FDA approval and a $2.78B market opportunity.
Trial Library and American Oncology Network Partner to Expand Patient Access to Cancer Clinical Trials
Trial Library, a leader in AI-enabled clinical trial matching and patient navigation with a strong reputation in oncology, has partnered with American Oncology Network (AON), one of the nation's ...