Regulatory Filings and Submissions

Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder

March 14, 2023

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

FDA Approves Pfizer’s New Migraine Nasal Spray

March 14, 2023

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.

Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market

March 10, 2023

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

EMA Guidance on Paediatric Investigation Plans

March 02, 2023

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination

February 22, 2023

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

FDA Approves First Treatment for Geographic Atrophy

February 22, 2023

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

FDA Announces BsUFA III Regulatory Science Program to Support Future Research

February 17, 2023

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Recent Initiatives to Support Development of Medicines for Children

February 07, 2023

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

FDA Interactions with Industry Under Scrutiny

February 02, 2023

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

The COVID-19 Pandemic and Its Positive Impact on RNA Drug Development

February 01, 2023

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.