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FDA Grants First Approval for Niemann-Pick Disease, Type C Treatment FDA The FDA has approved Miplyffa (arimoclomol) as the first-ever treatment for Niemann-Pick disease, type C (NPC), a rare genetic disorder that causes severe neurological symptoms and organ dysfunction.
EFSA Peer Review Highlights Data Gaps and Safety Concerns in Triclopyr-Butotyl Herbicide Assessment EFSA EFSA's peer review of triclopyr-butotyl herbicide identifies effectiveness on grasslands but raises concerns in mammalian toxicology, ecotoxicology, and environmental impact. Further data and assessments are required to ensure safe use in the EU.
EFSA Panel Confirms Safety of Glucosyl Hesperidin as a Novel Food Ingredient EFSA EFSA's latest scientific opinion verifies the safety of glucosyl hesperidin (GH) for use in beverages, confectionery, and supplements. A 90-day toxicity study supports a safe intake level, ensuring the novel food is fit for the general population, including children and adults.
ECHA Adds New Hazardous Chemical to SVHC List ECHA European Chemicals Agency (ECHA) has expanded its Candidate List of substances of very high concern (SVHC) to include 241 entries. The latest addition, bis(α,α-dimethylbenzyl) peroxide, is known for its reproductive toxicity and is commonly utilized as a processing aid, such as a flame retardant.
PFAS Restrictions: June RAC and SEAC Meeting Highlights ECHA Discover provisional conclusions from the June RAC and SEAC meetings on PFAS restrictions. Learn about impacted sectors, key concerns, future evaluations, and additional outcomes.
ECHA Updates Research Needs for Hazardous Chemicals Regulation ECHA The European Chemicals Agency (ECHA) updates its report on hazardous chemicals regulation, highlighting key research areas such as protection against harmful chemicals, environmental pollution, alternatives to animal testing, and improved data availability
Ensuring Pharmaceutical Quality: CDER's Comprehensive Approach FDA CDER CDER ensures pharmaceutical quality by monitoring manufacturing facilities and conducting risk-based inspections to guarantee the safety and effectiveness of medications.
EMA Recommends Suspension of 17-OHPC Medicines EMA EU EMA recommends suspending 17-OHPC medicines in the EU due to potential cancer risk and lack of effectiveness in preventing premature birth.
EPA Announces Final Rule to Slash Toxic Emissions of Ethylene Oxide and Reduce Cancer Risk EPA Discover how EPA's stringent measures reduce ethylene oxide emissions, protecting communities near sterilization facilities while ensuring medical device supplies.
EPA Announces Standards to Curb Air Toxic Pollution in Gasoline Distribution Facilities EPA Learn how the EPA is combating toxic air pollution from gasoline distribution facilities, protecting public health and the environment.

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