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Less than a month after the FDA refused to review Alkermes’ new drug application for the company’s depression drug, the agency has changed its mind, according to a statement from the company. After it “clarified certain aspects of the NDA submission”, Alkermes said Monday that the FDA will now accept the application without requiring additional […]
Original Article: Alkermes Depression Drug Review Goes Ahead After FDA About-FaceNEXT ARTICLE
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...