FDA Approvals - FDA: Manufacturers Of TNF-Blocker Drugs Must Highlight Risk Of Fungal
FDA: Manufacturers Of TNF-Blocker Drugs Must Highlight Risk Of Fungal Infections (Medical News Today)
The U.S. Food and Drug Administration announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.
FDA Panel Says Pfizer's New Osteoporosis Drug Has Benefits But Use Should Be Restricted (Medical News Today)
A panel that advises the US Food and Drug Administration (FDA) on new drug approvals said the benefits of Pfizer's bone drug Fablyn for treating postmenopausal women with osteoporosis outweighed the risks but that use should be restricted to patients at high risk of fracture or who have tried other treatments without success.
Orthofix wins approvals for new orthopedic devices (Pharmaceutical Business Review)
Orthofix International has received 510(k) approval from the FDA for its new Pillar SA spine interbody device. The company also received a notification of approval to begin selling its CentroNail family of nailing systems in Japan.