Merck Loses 4th Bid to Expand Gardasil® to Older Women PR Log April 8, 2011 by Leslie Carol Botha FOR IMMEDIATE RELEASE In a long awaited decision1 the US FDA has ruled against Merck’s supplemental biologics application license (sBLA) for an indication to use Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine Recombinant] […]
Wrongly injected toddler fights leukaemia
Stuff.co.nz New Zealand NATALIE AKOORIE April 9, 2011 A Hamilton toddler who was mistakenly injected with a vaccine to prevent cervical cancer when he was just six weeks old has developed a rare form of leukaemia. Chace Topperwien began chemotherapy for the M7 strand of acute myeloid leukaemia on his second birthday last month, but […]
U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women
Merck News Room April 6, 2011 WHITEHOUSE STATION, NJ – April 6, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has completed its review of Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus […]
Connecting the Dots: Autism Awareness
Huffington Post April 5, 2011 by Alison Rose Levy – Health Journalist Dr. Ricki D. Robinson, M.D. honored World Autism Awareness Day with a thoughtful blog that superbly navigates between this steadily rising health concern and a medical model that has been challenged to find either an explanation or a treatment approach. Our health scientific […]
November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes
Food and Drug Administration Center for Biologics Evaluation and Review SUMMARY MINUTES VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE November 16 – 17, 2010 Silver Spring Hilton, Silver Spring, MD The Chair, Dr. Jack Stapleton, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 9:00 a.m. EST on November […]
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