Global pharmaceutical giant Lupin Limited announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg dosages. These tablets are set to be a generic equivalent of Livalo Tablets by Kowa Company Limited, […]
Pharmaceutical giant Merck has announced the initiation of its groundbreaking Phase 3 clinical program, CORALreef, focusing on MK-0616—a novel, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. MK-0616 is being evaluated for the treatment of adults suffering from hypercholesterolemia. The CORALreef program marks a historic milestone as the first Phase 3 clinical program for an […]
Zydus Lifesciences said that it has bagged final approval for Pitavastatin Tablets, 1mg, 2mg, and 4mg from the US Food and Drug Administration (FDA). Pitavastatin Tablets is the generic version of Livalo Tablets, which is a HMG-CoA reductase inhibitor. It has approval as an adjunctive therapy to diet in adults having primary hyperlipidemia or mixed […]
Novartis has secured approval from the US Food and Drug Administration (FDA) for its small interfering RNA (siRNA) therapy Leqvio (inclisiran) for its use in lowering low-density lipoprotein cholesterol (bad cholesterol or LDL-C). Leqvio FDA approval is for the drug to be administered in two doses a year, after an initial dose followed by another […]