The US drug regulator the FDA has made a final decision on the biological drug developed by Genzyme (Sanofi) for use in multiple sclerosis, alemtuzumab (Lemtrada), failing to approve the ...
Genzyme ran into a snag in April when the US Food and Drug Administration (FDA) rejected its application to produce Myozyme (alglucosidase alfa, rhGAA) in its 2,000–liter-scale facility under ...
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
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