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news.Perrigo secures tentative FDA approval for generic version of Suprep oral solution
The drug is indicated for the treatment of cleansing of the colon in preparation for colonoscopy in adults. Annual sales for the past 12 months ending July 2016
The drug is indicated for the treatment of cleansing of the colon in preparation for colonoscopy in adults. Annual sales for the past 12 months ending July 2016
In addition to the storage and transportation of drugs used in clinical trials as a service offered by all of Marken’s depots, Marken’s newest Moscow Depot will now
The unique multitenant cloud capabilities of Veeva Vault enable Daiichi Sankyo to easily streamline management of its critical content, providing external partners, such as CROs, the same level
Truvada was approved by the European Medicines Agency in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults aged 18
Validation of the MAA confirms that the submission is complete and starts the EMA's formal review process. The potential indication for neratinib is for the extended adjuvant treatment
PCD is a rare chronic inflammatory bowel disease that is caused by the malfunction of the immune system leading to inflammation, or swelling, across the lining of the
The new company, Afimmune, will continue the clinical development of DS102, a novel, anti-fibrotic compound. The company will study DS102 in NASH in addition to certain pulmonary disorders.
The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but
The Board consists of William Mitchell, M.D., Ph.D., Ronald Brus, M.D., W. Neal Burnette, Ph.D., and Christopher Nicodemus, M.D., F.A.C.P. Dr. Mitchell, M.D., Ph.D., Chairman of the Board
IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring