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Alkermes plc (ALKS) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461. FDA's target action date for the ALKS 5461 NDA is January 31, 2019.
Original Article: Alkermes Says U.S. FDA Accepts Review Of NDA For ALKS 5461 - Quick FactsNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...