FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients Source: FDA Press Releases
FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys
The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. Source: FDA Press Releases
HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods
HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods Source: FDA Press Releases
HHS, FDA Praise Consumer Brands Association’s Vow to Remove Artificial Colors from America’s Food Supply
Today the leadership of the U.S. Department of Health and Human Services (HHS) praised the Consumer Brands Association for its pledge on behalf of the makers of the nation’s food…
Official Company Name Change Announcement
PharmaLegacy Research LLC, dba. BTS Research Announces Expansion of their Headquarters & In Vitro Labs in their New San Diego Facility San Diego, CA We are excited to announce that…
Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research
The U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). Source: FDA Press…
FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
FDA is announcing today it has placed Elevidys and certain Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold due to new safety concerns that…
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
FDA is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. Source: FDA Press Releases
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine Source: FDA Press Releases
FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at…
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