Tag: FDA
Business & Industry
FDA Advances Real-Time Clinical Trials With AstraZeneca, Amgen
The U.S. Food and Drug Administration has unveiled a new regulatory initiative to enable real-time clinical trials, marking a structural shift in how drug...
Business & Industry
FDA Issues 3 Priority Vouchers for Psychedelic Drug Firms
The US Food and Drug Administration has awarded three additional Commissioner's National Priority Vouchers under its accelerated regulatory framework, targeting companies developing psychedelic-based therapies....
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The U.S. Food and Drug Administration has released a draft guidance outlining safety assessment standards for human gene therapy products that incorporate genome editing...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...
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