Pfizer and Astellas’ Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.

Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.

THE Ministry of Trade, Industry, and Tourism (MTIT)-Basilan has conducted a two-day training on food safety and processing technology for local cooperatives to ...

AbbVie has entered into a $700 million licensing agreement with IGI Therapeutics to co-develop ISB 2001, a promising ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

A CDC advisory panel vote to recommend against use of seasonal influenza vaccines containing small amounts of thimerosal ...