LOGO
LOGO

Quick Facts

Baxter, Halozyme Issue Update On HyQ Biologics License Application

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Baxter International Inc. (BAX) and Halozyme Therapeutics, Inc. (HALO) announced that the U.S. Food and Drug Administration, or FDA, is requesting additional information to complete its review of the HyQ Biologics License Application, or BLA.

Both the companies will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. At present, the companies expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data. The companies expect these requests to require additional time to complete and to delay their anticipated regulatory review and approval timeline.

For comments and feedback contact: editorial@rttnews.com

Business News

Global Economics Weekly Update - Jun 01 - Jun 05, 2026

June 05, 2026 16:18 ET
A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.

Latest Updates on COVID-19