Regulatory Oversight and Compliance

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.

Drug Companies Encouraged by FDA 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 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.

Germany Amends and Approves the New Medical Research Act

August 05, 2024

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

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.

First Approved Stelara Biosimilar Launched in Europe by STADA and Alvotech

July 30, 2024

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

CHMP Recommends 14 Medicines for Approval at July Meeting

July 26, 2024

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

FDA Asks for Input on Guidance Documents for Biosimilar Product Development

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.