Genzyme announced that the FDA is delaying final approval of the company's application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe disease.

The FDA said it is working with Genzyme during the company’s remediation to ensure availability of the company’s medically necessary drugs. “It is critical for the safety of the drug supply ...

French drug maker Sanofi-Aventis SA has agreed to buy Genzyme Corp. in a sweetened all-cash $20.1 billion deal that ends months of corporate haggling and positions Sanofi at the forefront of the ...

Genzyme Corp. expects the Food and Drug Administration to take action at its beleaguered Allston, Mass., plant to make sure products are made within regulations, following multiple manufacturing ...

CAMBRIDGE, Mass. — Genzyme Corp. said Wednesday the Food and Drug Administration will take enforcement action against the biotechnology company after a series of manufacturing problems stalled ...

In a major blow to Cambridge drug maker Genzyme, the Food and Drug Administration formally rejected a key multiple sclerosis treatment, Lemtrada, calling into question the integrity of clinical ...

But Genzyme, which initially predicted that the drug shortages would last six to eight weeks, has repeatedly backtracked on when supplies would be fully restored, as it has run into further ...

Genzyme began work on a therapy for Pompe disease ten years ago, and the company has invested nearly $1 billion to support the development program. In 2006, Genzyme received approval for Myozyme ...

U.S. regulators said they approved a new cancer drug from Genzyme Corp. for treating a type of childhood leukemia after other therapies have failed. In a statement, the Food and Drug ...

Genzyme said it has elected to negotiate with the FDA. The scope of the expected consent decree, which according to the company was not prompted by any one event, but rather a series of violations ...

Cambridge biotech Genzyme said Friday that it has resubmitted its application for a cdrug called Lemtrada that was rejected by the Food and Drug Administration in December. In a press release ...