EMA Recommends Ojemda for Paediatric Low-Grade Glioma
The European Medicines Agency (EMA) has recommended a conditional marketing authorisation for Ojemda (tovorafenib) to treat paediatric low-grade glioma in patients aged 6 months and older with specific BRAF gene alterations. This recommendation addresses an unmet medical need for a targeted therapy in this patient population.
EMA CHMP Recommends 12 Medicines for Approval
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and six for extension of therapeutic indications. This includes novel treatments for influenza, COVID-19, paediatric brain tumours, Parkinson's disease, and several biosimilar medicines.
FDA Draft Guidance on Medical Gases Certification Process
The FDA has issued draft guidance for industry on the certification process for designated medical gases. This guidance explains the certification process and annual reporting requirements, aiming to reduce regulatory burden for the medical gas industry. Comments are due by April 13, 2026.
FDA Guidance: Plausible Mechanism Framework for Individualized Genetic Therapies
The FDA has issued draft guidance outlining a plausible mechanism framework for developing individualized genetic therapies. This framework provides recommendations for generating substantial evidence of effectiveness and safety for these novel treatments. The comment period for this draft guidance closes on April 27, 2026.
FDA Draft Guidance Q&A on Food Traceability Records
The FDA has issued draft guidance in a Q&A format to help industry understand the requirements for additional traceability records for certain foods, as established by a final rule in 2022. Comments on this draft guidance are due by May 21, 2026.
FDA Guidance on Antimicrobial Drug Durations for Food Animals
The FDA's Center for Veterinary Medicine has issued guidance for sponsors of new animal drug applications concerning medically important antimicrobial drugs used in food-producing animals. The guidance aims to facilitate voluntary changes to define durations of use for these drugs to mitigate antimicrobial resistance.
Go Raw LLC Expands Cat Food Recall for Low Thiamine Levels
Go Raw LLC is expanding its voluntary recall of Quest Cat Food Chicken Recipe products due to low thiamine levels. The company is also stopping the sale of all Quest products until the issue is resolved. The expanded recall affects products distributed nationwide.