Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

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

New Drug for Rare Disorder Hypoparathyroidism Gets FDA Approval

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.

AstraZeneca Monotherapy for Gastric Cancer Gains Third Approval in China

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

First Nasal Spray for Anaphylaxis Approved by FDA

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

Drug Companies Encouraged by FDA to Participate in FY 2025 Site Visitation Program

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 Order on OTC Monograph Drugs Containing Acetaminophen Gets Renewed Comment Period

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.

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

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

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

Going Green: Updating Your Filings

Feliza Mirasol is the science editor for 

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

First Approved Stelara Biosimilar Launched in Europe by STADA and Alvotech

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.

FDA Asks for Input on Guidance Documents for Biosimilar Product Development

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

Regulatory Filings and Submissions