U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore potential rulemaking opportunities to tighten or ...
Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...
Noon, is tackling ALS and other neurological disorders with a bold, multi-targeted approach. Fueled by a personal encounter with an ALS advocate, Ben-Noon assembled a team of top scientists to develop ...
The agency’s approach to GRAS determinations has evolved over the intervening decades, with the last major change coming in 2016 with the publication of what is referred to as the final GRAS rule.
Cannabidiol (CBD) is increasingly recognized for its role as an antiseizure medication, especially for the management of Drug-Resistant Epilepsy (DRE). This ...
Activists have slammed the GRAS program, arguing it allows companies to “self-certify” the safety of food additives.
President Donald Trump's nominee to lead the Food and Drug Administration (FDA), Dr. Marty Makary, passed a key committee vote on Thursday morning.
Dyne Therapeutics’ DYNE-101 shows positive results in phase 1/2 ACHIEVE study. Read why DYN stock may rise with FDA approval and a $2.78B market opportunity.
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To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed ...
Takeda Pharmaceutical has a robust drug discovery pipeline to meet future clinical demand. Check out the upside and downside ...
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