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- FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine.
- BETHESDA, Maryland, January 25 /PRNewswire/ -- BETHESDA, Maryland, January 25 /PRNewswire/ --
- Research articles 2007-01-25
- CDC Advisory Committee on Immunization Practices Unanimously Votes to Add ROTATEQ®, Merck's New Rotavirus Vaccine, to the Childhood Immunization Schedule
- WHITEHOUSE STATION, N.J. -- -Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices ACIP unanimously voted to recommend that all infants, starting at six to 12 weeks of age, be vaccinated with ROTATEQR (rotavirus vaccine, live, oral, pentavalent)...
- Research articles 2006-02-21
- FDA Vaccines Advisory Committee Unanimously Agrees That Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of ROTATEQ®, Merck's Investigational Vaccine for Rotavirus Gastroenteritis
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from the Phase III clinical trials with 70,000 infants support the efficacy and safety of ROTATEQR (rotavirus vaccine, live, oral,...
- Research articles 2005-12-14
- FDA Advisory Committee Agrees That Clinical Data Support the Efficacy and Safety of Zostavax™, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee agreed that the extensive data from clinical trials in more than 40,000 people support the efficacy and safety of ZOSTAVAXTM (zoster vaccine live (Oka/Merck)), the...
- Research articles 2005-12-15
- FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of GARDASIL®, Merck's Investigational Cervical Cancer Vaccine; If Approved, GARDASIL Will Be the First Cervical Cancer Vaccine in the U.S
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from Phase II and Phase III clinical trials support the efficacy and safety of GARDASILR (quadrivalent human papillomavirus (Types 6,...
- Research articles 2006-05-18
Additional Resources
- North American Vaccine Announces Update On FDA Advisory Committee Meeting
- BELTSVILLE, Md.--BUSINESS WIRE--Nov. 26, 1996--North American Vaccine (AMEX:NVX) maintains its policy of not commenting on interactions with the U.S. Food and Drug Administration ("FDA") in, or the status of, the FDA's review of the company's products or on rumors or press reports appearing in the media regarding the business operations...
- Research articles 1996-11-26
- FDA Advisory Committee Concludes ACEL-IMUNE, Acellular Pertussis Vaccine Safe and Effective for Infant Use
- ST. DAVIDS, Pa.--HealthWire--Oct. 29, 1996--Wyeth-Lederle Vaccines and Pediatrics, a unit of Wyeth-Ayerst Laboratories, announced today that the Food and Drug Administration's FDA Vaccines & Related Biological Products Advisory Committee concluded that ACEL-IMUNER Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbeda is safe and effective when given to U.S. infants...
- Research articles 1996-10-29
- Rotarix® Receives Favorable Recommendation from FDA Advisory Committee
- NEEDHAM, Mass. -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that Rotarix([R]), an oral, two-dose rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants, received a favorable recommendation from the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee VRBPAC. AVANT licensed the technology for Rotarix([R])...
- Research articles 2008-02-21
- Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices
- - Expanded Guidelines to include availability of IXIAROR vaccine for Japanese Encephalitis - IXIARO now available in the U.S. for travelers to Asia, military personnel, others at high risk regardless of the length of visit ATLANTA, June 24 /PRNewswire/ -- Intercell AG (VSE: ICLL) today...
- Research articles 2009-06-24
- GlaxoSmithKline Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionKevin Wilson - Citigroup Yeah, thank you this Kevin Wilson from Citigroup in London. Three questions, if I may, JP. Firstly, in the U.S., the 2% decline in sales in the quarter. Could you break out the volume and any price element you saw, and perhaps also comment...
- Earnings calls 2007-07-25
- CDC Advisory Panel Votes to Recommend Merck's Shingles Vaccine, ZOSTAVAX®, for Vaccination of Adults Age 60 and Over
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices ACIP voted unanimously to recommend that adults 60 years of age and older be vaccinated with ZOSTAVAX[R] [Zoster Vaccine Live (Oka/Merck)] to help prevent shingles (herpes...
- Research articles 2006-10-25
- Addressing the Vaccine Financing Conundrum
- An Institute of Medicine IOM committee recommended a dramatic change in the national approach to financing immunizations in the United States. Major features were an insurance mandate to cover immunization, federal government subsidy for the purchase of vaccines, and vouchers for uninsured people. The National Vaccine Advisory Committee NVAC, while...
- White papers 2005-06-01
- Merck's New Cervical Cancer Vaccine, GARDASIL®, Unanimously Recommended by CDC Advisory Panel for Vaccination of Girls and Women 11 to 26 Years
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices ACIP voted unanimously to recommend that girls and women 11 to 26 years old be vaccinated with GARDASILR (Quadrivalent Human Papillomavirus (Types 6, 11, 16,...
- Research articles 2006-06-29
- CDC Finalizes Advisory Panel Recommendations for GARDASIL®, Merck's Cervical Cancer Vaccine
- WHITEHOUSE STATION, N.J. -- The U.S. Centers for Disease Control and Prevention CDC has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices ACIP for the use of GARDASIL([R]) [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] in girls and women ages 11 through 26. GARDASIL...
- Research articles 2007-03-22
- CDC Recommends ZOSTAVAX®, Merck's Shingles Vaccine, for All Appropriate Adults Aged 60 and Older
- WHITEHOUSE STATION, N.J. -- The U.S. Centers for Disease Control and Prevention CDC has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices ACIP for the use of ZOSTAVAX([R]) Zoster Vaccine Live for the prevention of shingles in adults aged 60 and older. ZOSTAVAX is the only vaccine...
- Research articles 2008-05-15
- European Regulators to Antigenics: Take Your Subset and Shove It
- News that a European advisory committee won't recommend approval of Antigenics' kidney cancer vaccine Oncophage vitespen provides yet another reminder -- in case anyone didn’t catch it the first few hundred times -- that regulators don't like retrospective subset data. by Trista Morrison
- Blog posts 2009-10-25
- Is Merck's Gardasil Linked To Lou Gehrig's Disease?
- Merck's Gardasil made big news late last week - and it wasn't all good. First, the FDA endorsed the vaccine to thwart genital warts in boys and young men. This is a mild plus for the drugmaker; Gardasil is already approved to ward off the human papillomavirus, or HPV, in...
- News items 2009-10-22
- Hill: FDA lax on conflict-of-interest rules
- The FDAs advisory committee conflict-of interest rules have been lax, says a House Government Reform Committee staff report. While the report hints at a broader scope of FDA problems with managing conflict-of interest issues, it narrows its focus to conflict-of interest issues within the agency's vaccine approval process. The report...
- Research articles 2000-10-01
- [3] Fence Post.(News)(Letter to the Editor)
- Caution on vaccines Thank you for speaking out in your editorial for the chickenpox vaccination decision being left up to parents ("Vaccine mandate not needed," Dec. 8). It is imperative that parents exercise informed consent and choice about their children's vaccinations. ...
- Research articles 2000-12-31
- U.S. panel backs AstraZeneca Plc's FluMist for kids
- AstraZeneca Plc's FluMist, the nasal spray influenza vaccine, was recommended for children 2 years to 4 years old by a U.S. panel of advisers. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted Tuesday to widen its recommendation for FluMist, which had been recommended for healthy...
- Research articles 2007-10-25
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