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In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance.
/PRNewswire/ -- SN BioScience (CEO Park Young-hwan) and Boryeong (CEO Jang Doo-hyun) signed a domestic manufacturing technology transfer and co-development...
This report provides a snapshot of the US Executive Branch priorities via daily schedules and the prior day's press releases.
This report provides a snapshot of the US Executive Branch priorities via daily schedules and the prior day's press releases.
Zydus Cadila announces USFDA approval for First Generic for Ibrutinib Capsules, 70 mg and gets eligibility for 180-day exclusivity Posted On: 2021-04-07 21:49:22 (Time Zone: Arizona, USA) Zydus Cadila has received final approval from the USFDA to market Ibrutinib Capsules, 70 mg and 140 mg (US RLD: Imbruvica Capsules). Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia. According to the USF...