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 ...

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 Food and Drug Administration questioned Friday whether a study submitted by Genzyme Corp. is strong enough to merit expanded approval of a drug to treat a rare illness known as 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 ...

Eleven months after rejecting a powerful multiple sclerosis drug considered key to the future of Cambridge biotech Genzyme, federal regulators Friday reversed themselves and approved sale of the ...

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 ...

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 ...

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 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 ...

Genzyme announced today it plans to submit its once-a-year drug, which is approved outside the U.S. for multiple sclerosis, to U.S. regulators after it was rejected in December. Genzyme announced ...

PARIS--French drug major Sanofi SA (SAN.FR) and its subsidiary Genzyme said Wednesday that the U.S. Food and Drug Administration would review in priority its new drug application for Gaucher ...