CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs. Idifarma, a contract development and manufacturing organization (CDMO), has launched a new ...
WASHINGTON, Oct. 11, 2023 /PRNewswire/ -- Ground-breaking new research shows that carbon removal solution biochar can play a significant role in global emissions reductions at the global and national ...
The US Food and Drug Administration has given a new Alzheimer’s drug the green light. The compound, lecanemab (Leqembi) is a monoclonal antibody (mAb), part of a new class of treatments that target ...
Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...
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Sangamo targets Q1 2026 BLA submission for Fabry gene therapy as FDA affirms accelerated pathway
CEO Alexander Macrae highlighted continued advancement of the clinical and preclinical pipeline, with a focus on managing cash resources. Macrae stated, "In September, we presented promising detailed ...
PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB) announced Tuesday that the FDA has accepted its request for a Type C Meeting scheduled to occur this month to discuss a proposed ...
FDA aims to address mounting criticisms of its accelerated approval pathway. In an important update to its policies for conducting clinical trials to support accelerated approval of important oncology ...
One of our primary goals at The Institute of Cancer Research, London, is to get innovative new treatments to patients as quickly as possible. The Accelerated Access Review (AAR), published in October ...
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