New Option For Uncontrolled Epilepsy On Horizon As US Accepts Cenobamate NDA
New potentially effective therapy for drug-resistant epilepsy, seen as the most pressing unmet need in this market, is on the horizon as FDA begins approval review of SK’s cenobamate, also marking a first for the Korean pharma industry.
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SK Biopharmaceuticals receives US approval for novel anti-epileptic drug, marking a major milestone for the South Korean firm in its goal of becoming a fully integrated global pharma and potentially boosting its huge planned IPO. Through its US subsidiary, the SK Group company will independently market and sell the product in the world’s biggest single market.
Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
The latest news on US FDA drug approvals.
After a lackluster year so far for South Korean biotech IPOs amid disappointing clinical trial news, investor interest is beginning to pick up, with several companies that have been under the spotlight slated to debut on the market in the coming months.