Clinical Trials Arena on MSN
FDA unveils new pathway to usher bespoke therapies to market
The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...
The decision aims to improve access to HRT by removing warnings about cardiovascular disease, breast cancer, and probable dementia. HHS has initiated removal of black box warnings on hormone ...
The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments ...
Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...
BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...
The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to ...
The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...
The other shoe has dropped for Roche’s bid to move Columvi into earlier treatment of diffuse large B-cell lymphoma (DLBCL) in the U.S. The FDA has declined to approve Columvi, in combination with the ...
The smart thermometer performs a check-up on your body temperature, cardiac, and pulmonary health in less than a minute.
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