FDA Approvals - FDA Approves Two New Indications For Rituxan(R) In Patients With
FDA Approves Two New Indications For Rituxan(R) In Patients With Non-Hodgkin's Lymphoma (Medical News Today)
Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved, after a Priority Review, two additional uses for Rituxan(R) (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). [click link for full article]
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]
FDA Issues Approvable Letter For Paliperidone ER For The Treatment Of Schizophrenia (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia. [click link for full article]