Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
A panel of medical experts open a discussion surrounding key treatment strategies in management of hepatocellular carcinoma (HCC). The session commenced with a brief introduction by Haumschild, ...
SAN DIEGO — Fewer than half of the cancer drugs approved under the US Food and Drug Administration's (FDA's) accelerated approval pathway between 2013 and 2017 have been shown to improve overall ...
Clinical Trials Arena on MSN
Gene editing takes centre stage in FDA’s new rare disease approval pathway
The aim of the pathway is to remove red tape for bespoke therapies designed for patients with rare diseases.
SAN DIEGO – Of the 46 cancer drugs that the U.S. Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% ...
MedPage Today on MSN
FDA proposes new approval pathway for rare disease gene therapy
Will consider data that includes "the experience of individuals," FDA commissioner says ...
Nearly 70% of cancer drugs granted FDA accelerated approval between 2011 and 2020 required safety updates within 4 years.“Postmarketing safety actions are common,” Maryam Mooghali, MD, MSc, internal ...
Dysphagia in cancers of the lip, oral cavity, and pharynx patients: Impact on cachexia, hospitalization, and racial disparities on outcomes. This is an ASCO Meeting Abstract from the 2025 ASCO Annual ...
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