Novo Nordisk Inc. - 2/7/2026. Country: New Jersey, United States. Record Type: 483

The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1).

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

Maiva Pharma Private Limited - 2/20/2026. Country: India. Record Type: 483