Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA. Ian ...

An inspector general report has raised some concerns about the FDA's accelerated approval pathway while also showing that the agency's controversial approval of Biogen's Alzheimer's disease drug ...

By Siddhi Mahatole June 22 (Reuters) - Regenxbio said on Monday the U.S. FDA has indicated that existing data for its ...

Qure N.V. (NASDAQ:QURE) was halted pending news on Wednesday and appeared set for a strong move higher once trading resumed ...

Experts discuss the FDA's Accelerated Approval Program, emphasizing its role in providing earlier access to innovative cancer therapies for patients. This episode focuses on the strategies for ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved Modeyso for patients with H3 K27M-mutant diffuse midline glioma. The therapy showed an overall ...

Less than half of the new drug indications approved through the accelerated approval pathway in the United States and the conditional marketing authorization pathway in Europe offered “high added ...

US regulators’ use of a speedy clearance pathway for a new frontline indication for asciminib for chronic myeloid leukemia (CML) has raised questions due to the number of medications already available ...

On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: ...