by Admin | Mar 14, 2026 | Regulatory Updates
A new Fierce Pharma report says the biopharma industry is heading into a more difficult 2026 as major companies confront a mix of patent expirations, slowing growth, and uneven commercial outlooks. The article, published March 13, 2026, says that among the world’s 25...
by Admin | Mar 14, 2026 | Regulatory Updates
The U.S. Food and Drug Administration has said it is recommending an additional, earlier MRI for patients with Alzheimer’s disease taking Leqembi (lecanemab). The agency stated that this added MRI should occur before the 3rd infusion, in addition to the monitoring...
by Admin | Mar 13, 2026 | Regulatory Updates
The UK’s updated clinical trials regulations will come into force on 28 April 2026, marking an important date for sponsors, researchers, and pharmacovigilance teams involved in CTIMPs. The Health Research Authority says the changes were developed after a 2022 public...
by Admin | Mar 13, 2026 | Regulatory Updates
The U.S. Food and Drug Administration has launched the FDA Adverse Event Monitoring System (AEMS), a new unified platform designed to modernize how adverse event reports are collected, analyzed, and accessed. According to the FDA, the system brings together reporting...
