Regulatory Authority Actions

FDA Approves Pediatric Indication for Non-Surgical Severe Thermal Burn Treatment

August 19, 2024

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

EMA Expands Indication for Bristol Myers Squibb Follicular Lymphoma Therapy

August 19, 2024

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

Two AstraZeneca Treatments for Endometrial Cancer Approved in EU

August 15, 2024

Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza.

New Drug for Rare Disorder Hypoparathyroidism Gets FDA Approval

August 14, 2024

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH.

AstraZeneca Monotherapy for Gastric Cancer Gains Third Approval in China

August 14, 2024

AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

First Nasal Spray for Anaphylaxis Approved by FDA

August 13, 2024

The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

FDA Order on OTC Monograph Drugs Containing Acetaminophen Gets Renewed Comment Period

August 08, 2024

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.

First Gene Therapy for Adults with Metastatic Synovial Sarcoma Approved by FDA

August 05, 2024

Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.

Demanding Impartiality

August 03, 2024

Potential conflicts of interest with advisory group members have led to EMA’s impartiality coming into questioned for some marketing authorization decisions.

Going Green: Updating Your Filings

August 02, 2024

The implementation of new quality control methods must be reported to regulators, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.