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news.MindMed receives innovation passport for GAD therapy from UK MHRA
This designation marks the beginning of the UK Innovative Licensing and Access Pathway (ILAP), which is designed to expedite the development and access of new medicines in the
This designation marks the beginning of the UK Innovative Licensing and Access Pathway (ILAP), which is designed to expedite the development and access of new medicines in the
This move grants Theratechnologies the ‘rights’ to potentially introduce treatments for familial chylomicronaemia syndrome (FCS), hereditary angioedema (HAE), and severe hypertriglyceridemia (sHTG) within the Canadian market. Under the
The single-asset focused partnership leverages Tubulis’ platforms, Tubutecan and Alco5, to create an ADC with stability and reduced off-target toxicity, addressing present treatment challenges. Under the agreement terms,
This designation is effective as of 27 November this year. Sparsentan was originally developed by Travere Therapeutics and was in-licensed to Renalys Pharma, which holds license for its
VELSIPITY already secured approvals in the European Union, the US, and other countries through Everest’s licensing partner, Pfizer. The acceptance was grounded on data from the ELEVATE UC
India has now become the third country to have access to this PD-1 inhibitor, following the US and China. The drug will be marketed under the brand name
This authorisation marks a first TROP2 ADC and the first fully approved domestically developed ADC for marketing in China. The approval of sac-TMT is based on the outcomes
The vaccine, which is approved for adults currently, may soon be available for use in adolescents aged 12 to 17 years if the extension is granted. This move
This investigational ribonucleic acid interference (RNAi) therapeutic is aimed at treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The FDA has set a prescription drug user fee act (PDUFA) action
The approval makes the company the first commercial biotech to receive such a license for this cell therapy type. Derived from the umbilical cord blood of humans, the