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A fully human monoclonal antibody, Libtayo acts on the immune checkpoint receptor PD-1 on T cells. It is said to be the first-line monotherapy approved for advanced non-small

This designation is set to provide opaganib with seven years of marketing exclusivity upon approval for this indication. Orphan drug status may also offer additional benefits, including potential

This follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states,

RAG-18 is claimed to be the first saRNA therapeutic to receive ODD status. DMD and BMD  are caused by mutations in the DMD gene. The FDA grants ODD

The launch may lead to additional milestone payments, minimum sales payments, and royalties for RedHill on net sales. Talicia is the only low-dose rifabutin-based therapy which received approval

This asset is being assessed to treat patients with relapsed or refractory extensive-stage small-cell lung cancer (ES-SCLC) who have shown disease progression on or following treatment with platinum-based

This designation is a critical step in accelerating the drug’s development and review process, recognising the urgent need for new treatments in this area. Arthrosi Therapeutics founder and

ENHERTU, a HER2 directed a DXd antibody drug conjugate (ADC), was discovered by Daiichi Sankyo and is being jointly developed and commercialised by Daiichi Sankyo with AstraZeneca. The

This move comes as part of the research collaboration agreement initiated on 21 December 2021. As per the 2021 deal, Aarvik carried out the discovery and preclinical development