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FDA Approvals - AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For


AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths (Medical News Today)
AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH(R) for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation.

UCB's CIMZIA(R) (certolizumab Pegol) Approved By The U.S. FDA For Adult Patients Suffering From Moderate To Severe ... (Medical News Today)
UCB announced that the U.S. Food and Drug Administration (FDA) approved Cimzia , the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
 

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