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 ...
KRRO-110 is the first RNA editing development candidate from Korro’s proprietary OPERA TM platform and is currently being evaluated in the Phase 1/2a REWRITE clinical study for AATD. Dosing of the ...
President Donald Trump's nominee to lead the Food and Drug Administration (FDA), Dr. Marty Makary, passed a key committee vote on Thursday morning.
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RFK Jr. targets FDA’s ‘self-certify’ food additive programActivists have slammed the GRAS program, arguing it allows companies to "self-certify" the safety of food additives.
The delays and frequent queries raised by CDSCO have become a major obstacle for applicants, particularly startups and ...
Plus: Gene therapy with bioengineered blood cells, a possible quantum computing milestone, a new space telescope, how to not ...
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.
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 ...
Gemini Bioproducts, LLC ("GeminiBio"), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Fort Lauderdale-based ...
John Arena is interim president of global pharma services at Cencora, managing a team that offers a broad range of solutions ...
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