Since the European Medicines Agency (EMA) approval of omalizumab in 2005 as the first ever biologic for severe asthma, the ...

By Mariam Sunny and Siddhi Mahatole (Reuters) -French drugmaker Sanofi said the U.S. Food and Drug Administration has ...

The U.S. Food and Drug Administration has warned the pharmaceutical ... Practice for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham, Massachusetts.

Sanofi (NASDAQ:SNY) has received EU regulatory approval for its drug Sarclisa for the treatment of newly diagnosed multiple myeloma patients. The drug was approved for use in combination with a ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

The FDA has approved a once-daily therapy that addresses ... Mavorixafor was licensed from Genzyme, a Sanofi subsidiary. With the molecule’s approval, X4 now owes a $7 million milestone payment ...

Research estimates about 4,000 men in the US have Fabry disease. An ongoing lawsuit alleges that the Fabrazyme drug became contaminated and that Genzyme misled patients as to the safety of the drug ...

Jim Geraghty, longtime veteran of Genzyme and other Boston-area biotechs, wrote a book to "let people know that if we take this orphan-drug revolution for granted, it's not destined to continue on ...

"Sanofi has been working closely with the FDA to fulfill this post marketing requirement and is still following this activity," Sanofi, which acquired Genzyme and Clolar more than a decade ago ...

Genzyme, headquartered in Cambridge, was sold to French drugmaker Sanofi-Aventis in 2011 for about $20 billion. The newly-named Sanofi Genzyme, a subsidiary, is building a new $80 million, 72,000 ...

CAMBRIDGE, Mass.--Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa.This enzyme replacement ...

PARIS (Reuters) - Sanofi and its subsidiary Genzyme said on Thursday that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to olipudase alfa. This enzyme ...