Regulatory Filings and Submissions

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.

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 01, 2023

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

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

January 23, 2023

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Publishes Guidance on Labeling Drugs and Biological Products

January 16, 2023

The guidance provides examples of required and recommended information in the Dosage and Administration section.

Bylvay Alagille Syndrome Submitted for Regulatory Filings to FDA, EMA

December 21, 2022

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

Are Obesity Drugs the Next Blockbusters?

November 02, 2022

New medications show exciting outcomes for weight loss.