Tag: US FDA
Calliditas Therapeutics bags TARPEYO FDA approval for IgAN
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) has announced a landmark FDA approval for TARPEYO (budesonide) delayed release capsules, aimed at reducing kidney function ... Read More
Zydus Lifesciences gains FDA approval for Cyclophosphamide Capsules
Zydus Lifesciences Limited, a leading pharmaceutical company, has achieved a significant milestone by receiving final approval from the United States Food and Drug Administration (USFDA) ... Read More
Granules India secures ANDA approval for Pantoprazole Sodium Tablets from FDA
Granules India Limited, a prominent player in the pharmaceutical industry, has announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated ... Read More
Lupin gets FDA nod for Allopurinol Tablets, eyeing share in $88m market
Global pharmaceutical company Lupin Limited has announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New ... Read More
Cipla’s InvaGen Pharmaceuticals recalls Vigabatrin over seal integrity concerns
InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of Cipla Limited, has announced a voluntary recall of one lot of Vigabatrin for Oral Solution, USP 500mg, to ... Read More
Zydus Lifesciences bags FDA approval for Lacosamide Tablets in seizures
Zydus Lifesciences Limited, a prominent player in the pharmaceutical industry, has recently received final approval from the United States Food and Drug Administration (USFDA) to ... Read More
Arcutis Biotherapeutics gets ZORYVE FDA approval for seborrheic dermatitis
Arcutis Biotherapeutics, Inc., a pioneer in immuno-dermatology, has announced the U.S. Food and Drug Administration's (FDA) approval of their new drug application for ZORYVE (roflumilast) ... Read More
Abbott launches GLP Systems Track lab automation system in US
Abbott has announced the launch of its innovative lab automation solution, GLP systems Track, which has recently received approval from the U.S. Food and Drug ... Read More
Zydus Lifesciences gains FDA approval for Darunavir Tablets in HIV-1 treatment
Zydus Lifesciences Limited, a prominent name in the global pharmaceutical industry, has achieved a significant milestone with the United States Food and Drug Administration (FDA) ... Read More
FDA approves Vertex and CRISPR Therapeutics’ CASGEVY for sickle cell disease
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