This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Antibe Therapeutics is a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation
Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Morepen Laboratories approves hiving off of medical devices business
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
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