CDC Announce Number of Expired Flu Vaccines Administered Last Season
There were 125 reports of 192 patients receiving expired injectable inactivated influenza vaccines during the last flu season.
All articles by Steve Duffy
Gonorrhea Test ResistancePlus GC Granted Breakthrough Device Status
The FDA has granted Breakthrough Device designation to ResistancePlus GC,, a test that detects ciprofloxacin susceptibility.
First Zika Diagnostic Test Cleared for Marketing in the US
The FDA has cleared the ZIKV Detect 2.0 lgM Capture ELISA (InBios) for testing of Zika virus immunoglobulin antibodies in blood.
Microbial Growth Prompts Recall of Two Injectable Drugs
Heritage Pharmaceuticals has initiated a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) after microbial growth was detected.
FDA Clears Tests for Chlamydia, Gonorrhea Using Extragenital Samples
The FDA has cleared the Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) to detect chlamydia and gonorrhea via throat and rectum samples.
Kaposi Sarcoma Treatment Gets Breakthrough Therapy Designation
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pomalyst (pomalidomide; Celgene) for the treatment of patients with Kaposi sarcoma.
Treatment for Severe Malaria Receives Breakthrough Therapy Status
The Food and Drug Administration has granted an investigational treatment for severe malaria Breakthrough Therapy designation.
FDA to Review Baloxavir sNDA for Patients at High-Risk for Flu Complications
The Food and Drug Administration has accepted for review the supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil; Genentech) for the treatment of influenza in patients at high risk of complications.
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