Archive for July 2025
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks Source: FDA Press Releases
Read MoreFDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers Source: FDA Press Releases
Read MoreFDA 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
Read MoreFDA 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
Read MoreHHS, 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
Read MoreHHS, 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 and beverage products to remove certified Food, Drug & Cosmetic (FD&C) petroleum-based colors from America’s food supply. Source: FDA Press Releases
Read MoreOfficial 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 BTS Research is now operating under a new name: BioLegacy Research This new identity reflects our new leadership, expanded service platforms, and a renewed focus…
Read MoreStanford 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 Releases
Read MoreFDA 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 the study participants are or would be exposed to an unreasonable and significant risk of illness or in Source: FDA Press Releases
Read MoreFDA 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
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