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- 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
- 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 Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS™ , Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration FDA voted unanimously to recommend accelerated FDA approval of ISENTRESS[TM] raltegravir in combination with other antiretroviral therapy ART for the treatment of HIV infection in treatment-experienced patients...
- Research articles 2007-09-05
- 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 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
- Merck's COX-2 Inhibitor Vioxx Receives Preliminary FDA Approval.
- VIOXX ROFECOXIB, the COX-2-specific inhibitor from Merck & Co. Inc., was recommended for approval for treating osteoarthritis and acute pain by a Food and Drug Administration advisory committee. FDA is scheduled to consider final approval for VIOXX ROFECOXIB, the COX-2-specific inhibitor from Merck &...
- Research articles 1999-04-26
- Merck, Schering Unable to Stop Digging in Vytorin Mess
- As an example of how not to handle a corporate crisis, it's hard to beat the growing scandal over Vytorin. That's the blockbuster anti-cholesterol drug whose clinical-trial data Merck and Schering-Plough sat on for a year or two after it showed that Vytorin was apparently no better than a...
- Blog posts 2008-04-14
- FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR® 20 mg
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA joint panel of the Nonprescription Drugs Advisory Committee NDAC and the Endocrinologic and Metabolic Drugs Advisory Committee EMDAC voted against recommending approval at this time of the over-the-counter OTC use of MEVACOR([R])...
- Research articles 2007-12-13
- 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
- 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
- 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
- Merck Receives Not Approvable Letter from FDA for OTC MEVACOR® 20 mg
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration FDA to its New Drug Application NDA seeking approval for over-the-counter OTC MEVACOR([R]) lovastatin 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews...
- Research articles 2008-01-25
- Fda Committee Recommends Fosamax®, Merck's Osteoporosis Drug
- WEST POINT, Pa.--BUSINESS WIRE--July 13, 1995--An advisory committee of the U.S. Food and Drug Administration Thursday unanimously recommended that the FDA clear for marketing FosamaxR alendronate sodium for the treatment of osteoporosis in postmenopausal women.
- Research articles 1995-07-13
- 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
- Glaxo's U.S. Cervarix Approval More Important for Company's Pride than for Sales
- EP Vantage submits: GlaxoSmithKline GSK finally appears set to win approval for its cervical cancer vaccine Cervarix in the US, an event that could now occur in a couple of weeks' time and bring a long and tortuous journey to a conclusion. Having first filed the vaccine in March...
- External links 2009-09-11
- Reform Moves Stir Talk of Bundled Payments
- There’s a widespread belief among healthcare providers that we’re heading for Medicare payment changesâ€"and perhaps reimbursement changes in the broader systemâ€"that will reward collaboration between hospitals and physicians. While the Senate Finance Committeeâ€"the epicenter of national reform legislationâ€"has only suggested bundling of hospital and post-acute care payments, there are signs...
- Blog posts 2009-06-18
- Cervarix gets CDC nod; Gardasil-for-boys slighted
- The HPV vaccine saga continues. Less than a week after we got the FDA nod on GlaxoSmithKline's Cervarix shot and a new use in males for Merck's Gardasil, the Centers for Disease Control and Prevention has weighed in. And though the public-health agency sided with FDA on Cervarix, it wasn't...
- News items 2009-10-22
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