A two-year long shortage of an enzyme replacement therapy for patients with Fabry disease may soon be over, according to its manufacturer.
The Genzyme unit of French drugmaker Sanofi said it has received FDA approval to begin producing agalsidase beta (Fabrazyme) at its new manufacturing plant in Framingham, Mass.
"Approval of the Framingham site allows Genzyme to begin the proces...
The maker of staples used in thoracic surgery has recalled all lots of two product lines after receiving reports of 13 serious post-operative injuries and three deaths.
In a statement, Covidien noted that Duet TRS staples have "the potential to injure adjacent anatomical structures within the thorax" and could cause potentially fatal harm to a patient.
Included in the recall are a...
Women in Europe and Latin America have received mixed messages from their governments about whether breast implants from a now-defunct French company should be removed.
The implants, made by Poly Implant Prostheses (PIP) and never available in the U.S., were manufactured with a cheap industrial grade of silicone, rather than medical grade. The French government also found that they have...
The maker of an injectable polymyxin B and vecuronium bromide has recalled several lots of each product because of glass particles in the solutions.
The injectables, initially recalled by Bedford Laboratories on Aug. 2, 2011, include: Polymyxin B for Injection USP, 500,000 units per vial (lots 1942980, expiration date Aug., 2013 and 1895027, expiration date June, 2013) Vecuronium Bromi...
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