Arrowhead Pharmaceuticals has received approval from the Australian Therapeutic Goods Administration (TGA) for Redemplo (plozasiran) to treat familial chylomicronemia syndrome (FCS).
Sustained efficacy of ULTOMIRIS was observed on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels and the secondary endpoints of LDH level reduction
Under the agreement, Dr. Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including existing contractual obligation and inventory.
The program is intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they
Previously known as COR-001, ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb), targeting residual inflammatory cardiovascular risk in patients living with advanced chronic kidney disease (CKD).
The FDA has approved Kanjinti for all approved indications of the reference product Herceptin to treat HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal
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