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The FDA’s accelerated-approval process was designed to help people access life-saving drugs. But gaps in communication could mean that people are undergoing treatments known to be ineffective. The FDA’s accelerated-approval process was designed to help people access life-saving drugs. But gaps in communication could mean that people are undergoing treatments known to be ineffective.
/PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary,...
The U.S. Food and Drug Administration (FDA) has approved a drug for treating patients with a rare form of a neurological disease called amyotrophic lateral sclerosis (ALS).
Blood-based measurement of neurofilament light chain provides compelling evidence to support an accelerated drug approval by the FDA. The decision has positive implications for NfL blood testing as... | June 18, 2023