Quantcast

Latest Cladribine tablets Stories

2011-03-02 01:25:00

ROCKLAND, Mass., March 2, 2011 - EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS). (Logo: http://photos.prnewswire.com/prnh/20101126/SF07905LOGO-b) A complete response...

2010-11-26 01:18:00

ROCKLAND, Mass., Nov. 26, 2010 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011. The FDA granted Priority Review status for Cladribine Tablets in July of 2010, reducing the standard 10-month review period to six months, which was set to end on...

2010-07-28 02:38:00

ROCKLAND, Mass., July 28 /PRNewswire/ -- EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS). The application also has been granted a Priority Review designation by the FDA, which means the review period for the NDA is reduced. The goal for completing a Priority Review is six...

2010-01-21 00:30:00

ROCKLAND, Mass., Jan. 21 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today the online publication of the results from the CLARITY(1) Phase III trial using Cladribine Tablets (EMD Serono's proprietary investigational oral formulation of cladribine) in The New England Journal of Medicine(2). The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in 1,326 people with...

2009-11-30 08:06:00

ROCKLAND, Mass., Nov. 30 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS). "The company will work closely with the FDA to fully understand FDA's concerns and define a...

2009-09-30 11:02:00

ROCKLAND, Mass., Sept. 30 /PRNewswire/ -- EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered...


Word of the Day
mallemaroking
  • Nautical, the visiting and carousing of sailors in the Greenland ships.
This word is apparently from a confusion of two similar Dutch words: 'mallemerok,' a foolish woman, and 'mallemok,' a name for some persons among the crew of a whaling vessel.