FDA grants Otsuka’s Sibeprenlimab breakthrough therapy designation in IgAN

Pallavi Madhiraju- February 17, 2024 0

In a significant development for the treatment of kidney disease, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sibeprenlimab, an ... Read More

Lupin bags tentative FDA approval for Tolvaptan Tablets, a generic of Jynarque

Pallavi Madhiraju- October 5, 2023 0

Lupin Limited, a global pharmaceutical powerhouse, proudly announces that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for ... Read More

Unichem Laboratories gets FDA approval for Aripiprazole Tablets, USP

pallavi123- July 1, 2021 0

Unichem Laboratories said that it has secured a tentative approval for abbreviated new drug application (ANDA) of Aripiprazole Tablets, USP, 2mg, 5mg, 10mg, 15mg, 20mg, ... Read More