April 22, 2011 Dear Dr. Hamburg: I have just read a press release issued by Roche announcing the FDA approval of its cobas HPV Test. The press release states “The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing.” It is […]
HEALTH CANADA APPROVES GARDASIL® FOR WOMEN UP TO AGE 45
KIRKLAND, QC, April 26 /CNW Telbec/ – Today, Merck announced that Health Canada has extended the indication of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine] in women up to the age of 45. Merck’s HPV vaccine is now approved for girls and women nine through 45 years of age for […]
FDA: Infants May Get Meningococcal Vaccine
By Joyce Frieden, News Editor, MedPage Today WASHINGTON — The FDA has approved the first meningococcal vaccine for use in toddlers and infants as young as nine months of age. The vaccine, called Menactra, is already approved for use in people ages 2 through 55 for prevention of invasive meningococcal disease caused by Neisseria meningitidis […]
FDA approves Roche HPV test to identify cervical cancer risk
Submitted by Mechele R. Dillard The U.S. Food and Drug Administration has approved a test identifying women at highest risk for cervical cancer. The U.S. Food and Drug Administration has approved the Roche cobas HPV(Human Papillomavirus) Test, which identifies women at highest risk for cervical cancer. It can potentially help doctors make earlier, more accurate […]
Parents of Daughters ; Women Injured from Gardasil React to FDA Decision
Why are medical consumers the medical experiments? Safety and efficacy studies should be conducted for all intended age groups before market release. SANE Vax Inc. April 19, 2011. PR Log. On April 7, 2011 the media broke the news about the U.S. FDA’s ruling against Merck’s supplemental biologics license application (sBLA) for an indication […]
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