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The CRL, dated 22 October 2024, comes ahead of the Generic Drug User Fee Amendments of 2022 (GDUFA) goal date set for 29 October 2024. Ketamine, an essential

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

The acquisition bolsters AscellaHealth’s capabilities to serve international manufacturers and patients in more than 70 countries across the EU, Asia, Africa, Australia and the Americas. CHAPPER healthcare is

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’

The CRDAC’s positive vote is a pivotal step towards the potential approval of elamipretide, a first-in-class mitochondria-targeted therapy. The committee concluded with a 10 to 6 vote that