Highlights
FDA grants two designations for GenFleet’s drug candidate SLS009
The fast track and orphan drug designations have been awarded for GFH009 (highly selective CDK9 inhibitor) to treat a
Fermion receives IND approval in China for pain relief drug FZ008-145
A selective second-generation Nav1.8 inhibitor, FZ008-145 is designed to provide non-addictive pain relief. This Nav1
AbbVie introduces Produodopa for advanced Parkinson’s in EU
The treatment is indicated for use in PD patients experiencing severe motor fluctuations and hyperkinesia or dyskines
FDA grants orphan drug status to Ractigen’s RAG-18 for DMD and BMD
RAG-18 is claimed to be the first saRNA therapeutic to receive ODD status. DMD and BMD Â are caused by mutations in
RedHill launches Talicia in UAE to treat H. pylori infection
The launch may lead to additional milestone payments, minimum sales payments, and royalties for RedHill on net sales.
GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status
This asset is being assessed to treat patients with relapsed or refractory extensive-stage small-cell lung cancer (ES
FDA grants Fast Track Designation to Arthrosi Therapeutics’s AR882 for gout treatme
This designation is a critical step in accelerating the drug’s development and review process, recognising the
EMA validates Type II Variation application for ENHERTU for breast cancer treatment
ENHERTU, a HER2 directed a DXd antibody drug conjugate (ADC), was discovered by Daiichi Sankyo and is being jointly d
Aarvik announces ADC option exercise by collaboration partner ArriVent
This move comes as part of the research collaboration agreement initiated on 21 December 2021. As per the 2021 deal,
FDA grants priority review for Bavarian Nordic’s chikungunya vaccine BLA
The vaccine candidate is a virus-like particle (VLP)-based, adjuvanted vaccine designed for active immunisation again
Persist AI and Nivagen to develop AI-driven LAI manufacturing process
The collaboration between Persist AI and Nivagen will leverage AI-based formulation technology of Persist alongside N
Sandoz’s Enzeevu secures FDA approval for nAMD treatment
Enzeevu is designed to improve and maintain visual acuity in patients suffering from nAMD, a condition that is a prim