Tag: FDA
BioPharma
Trump Order Targets Faster Psychedelic Drug Reviews by FDA
The Trump administration has introduced a new executive order designed to accelerate Psychedelic Drug Reviews, marking a notable policy move aimed at expediting regulatory...
Business & Industry
FDA Advisory Panel to Assess Oversight of Peptide Substances
The U.S. Food and Drug Administration is preparing to revisit its stance on a group of peptide substances, as its Pharmacy Compounding Advisory Committee...
Clinical Trials
FDA Outlines Genome Editing Safety Guidance for Therapies
The U.S. Food and Drug Administration has released a draft guidance outlining safety assessment standards for human gene therapy products that incorporate genome editing...
Business & Industry
FDA Seeks Input on National Priority Voucher Pilot Program
The U.S. Food and Drug Administration has initiated a new phase of stakeholder engagement for its national priority voucher pilot program, announcing a public...
Business & Industry
Cosentyx Secures FDA Approval for Paediatric HS Treatment
Novartis has received approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) for the treatment of paediatric patients aged 12 years...
Business & Industry
US FDA Approves Leucovorin for Rare Autism-Like Disorder
The U.S. Food and Drug Administration on Tuesday authorized the use of leucovorin, a long-established generic medicine, for the treatment of a rare genetic...
BioPharma
Enhertu Priority Review in HER2-Positive Early Breast Cancer
The supplemental Biologics License Application - sBLA for Enhertu - trastuzumab deruxtecan by AstraZeneca and Daiichi Sankyo has been accepted as well as granted...
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