FDA Approvals - FDA Issues Approvable Letter for Paliperidone ER for the Treatment
FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia (RedNova)
TITUSVILLE, N.J., Sept. 29 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S.
Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of (RedNova)
INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company today announced that it is weighing options for the further development of ruboxistaurin mesylate in light of a request by the Food and Drug Administration (FDA) for an additional, three-year, Phase 3 clinical trial.
FDA Issues Approvable Letter To Ortec For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients' Hand (Medical News Today)
Ortec International, Inc.(OTC Bulletin Board: OTCI), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration (FDA) that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility. [click link for full article]