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A small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation, Orkedia Tablets suppresses parathyroid hormone (PTH) secretion as it acts on the

The designation will provide certain benefits to Faron including exemption of FDA application fees, tax credits for qualified trials, and on receiving regulatory approval, will get market exclusivity.

These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. As part of the

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody. It is the company’s other new antibody with a priority review following the marketing approval of cadonilimab. After the

The first-in-class, investigational monoclonal antibody ALE.C04 has been developed for targeting exposed CLDN1 in specific on cancer cells. It is designed to treat cancer by remodelling of the

The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives

These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in

MAb-AR20.5 is an IgG1k type murine monoclonal antibody that attaches specifically to the circulating and tumour-associated antigen (MUC1) expressed on pancreatic cancer cells. It is said to become

The regulator has provided the Prescription Drug User Fee Act (PDUFA) date of 20 December this year for the review. Currently approved under accelerated approval, TARPEYO is developed