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The FDA’s ODD status is granted to investigational assets for treating diseases affecting less than 200,000 people in the US. This designation provides incentives such as tax credits for

Denosumab has received approval in several countries and regions under different brand names for multiple indications, including osteoporosis treatment in postmenopausal women at high risk of fractures, among

Dubbed SPRINX-1 Study, the trial aims to assess the safety and efficacy of RXRG001 in treating radiation-induced xerostomia (RIX) [dry mouth] and hyposalivation conditions. A proprietary product created

Under the terms of the agreement, TerSera will pay MacroGenics $40m upon closing. MacroGenics is also eligible for up to $35m in additional sales milestone payments. The transaction

Under the contract, which extends through December 2037, Samsung Biologics will carry out the production at its biomanufacturing site in Songdo, South Korea. This latest agreement took Samsung

This recommendation paves the way for a new therapy option for adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk

This designation is a significant milestone for the monoclonal antibody plasma kallikrein inhibitor, which is designed to provide long-acting prevention of HAE attacks. Navenibart is effective even without

This partnership will see RTI, alongside investors such as Genoa Ventures and Anzu Partners, investing in Codetta Bio. RTI will also integrate Codetta Bio’s technology into research initiatives.

The platform can detect unintended pH changes, bolster formulation stability, and lower viscosity for ensuring efficacy and maximising delivery of drugs. S-HiCon incorporates a preliminary ‘concentration gate check’