Tag: US FDA

FDA approves Vertex and CRISPR Therapeutics’ CASGEVY for sickle cell disease

businessnewstoday- December 9, 2023

Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics have announced a significant milestone in medical science with the U.S. Food and Drug Administration's (FDA) approval of CASGEVY ... Read More

Indoco Remedies secures FDA tentative approval for Canagliflozin Tablets

businessnewstoday- December 6, 2023

Indoco Remedies Ltd., a renowned player in the global pharmaceutical industry, has announced receiving tentative approval from the United States Food and Drug Administration (USFDA) ... Read More

Granules India gains FDA approval for Sildenafil oral suspension ANDA

businessnewstoday- December 4, 2023

Granules India Limited has announced a major achievement with the US Food & Drug Administration (US FDA) approving its Abbreviated New Drug Application (ANDA). The ... Read More

FDA approves Ambio’s generic version of Forteo developed in collaboration with Apotex

businessnewstoday- December 3, 2023

Ambio, Inc., a leader in biotech innovation specializing in peptide drugs and complex generics, has announced that its generic version of Forteo (teriparatide injection), developed ... Read More

Zydus Lifesciences announces FDA approval for heart failure drug, Ivabradine Tablets

businessnewstoday- December 2, 2023

Zydus Lifesciences Limited, a significant player in the pharmaceutical industry, has received final approval from the United States Food and Drug Administration (FDA) for its ... Read More

Lupin Limited launches Turqoz Tablets in US, aims to expand contraceptive market

businessnewstoday- December 2, 2023

Global pharmaceutical giant Lupin Limited has made a significant entry into the U.S. contraceptive market with the launch of Turqoz (Norgestrel and Ethinyl Estradiol) Tablets ... Read More

Lupin obtains tentative FDA approval for generic Canagliflozin Tablets

businessnewstoday- November 24, 2023

Global pharmaceutical leader, Lupin Limited, announced its significant achievement of receiving tentative approval from the United States Food and Drug Administration (U.S. FDA) for its ... Read More

Strides Pharma subsidiary receives FDA approval for bowel prep solution

businessnewstoday- November 23, 2023

Strides Pharma Science Limited, through its subsidiary Strides Pharma Global Pte. Limited, Singapore, has recently achieved a significant milestone by receiving approval from the United ... Read More

FDA approves Ryzneuta by Evive Biotech for reducing febrile neutropenia in cancer patients

businessnewstoday- November 22, 2023

Evive Biotech, a global biopharmaceutical company and a subsidiary of Yifan Pharmaceutical Co. Ltd., along with New Jersey-based Acrotech Biopharma, a wholly-owned subsidiary of Aurobindo ... Read More

Lupin gains FDA approval for generic Pitavastatin Tablets, targeting $298m market

businessnewstoday- November 21, 2023

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 ... Read More