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FDA News Briefs for Monday, February 11, 2019

February 11, 2019

These Food and Drug Administration (FDA) developments came in last week:

 

FDA Warns of Risks Associated with Breast Implants

The FDA issued a letter to healthcare providers concerning the association between breast implants and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). The FDA is advocating for clinical awareness of BIA-ALCL symptoms (i.e., seroma, swelling, or pain around breast implant) regardless of breast implant type. More Information.

 

FDA Approves First Therapy for the Treatment of aTTP

The FDA approved Cablivi (caplacizumab-yhdp; Ablynx), a bivalent single-domain anti-von Willebrand factor, for use in combination with plasma exchange and immunosuppressive therapy for the treatment of acquired thrombotic thrombocytopenia purpura (aTTP) in adult patients. More Information.