Regulatory Filings and Submissions

Bristol Myers Squibb Follicular Lymphoma Therapy Gets Expanded EMA Indication

August 20, 2024

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

Non-Surgical Severe Thermal Burn Treatment Gets FDA Approval for Pediatric Indication

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.

FDA Approves New Drug for Rare Disorder Hypoparathyroidism

August 16, 2024

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

Gastric Cancer Monotherapy from AstraZeneca Gets Third Approval in China

August 16, 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.

FDA Encourages Drug Companies to Participate in FY 2025 Site Visitation Program

August 09, 2024

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

FDA Reopens Comment Period for Order Regarding OTC Monograph Drugs Containing Acetaminophen

August 09, 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.

FDA Approves First Gene Therapy for Adults with Metastatic Synovial Sarcoma

August 06, 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.

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.

STADA and Alvotech Launch First Approved Biosimilar to Stelara in European Market

July 29, 2024

STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab), in the European market, marking the second biosimilar brought to market by this partnership.

Input on Biosimilar Product Development Guidance Documents Sought by FDA

July 25, 2024

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.