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Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

Wyost® (denosumab-bddz) and Jubbonti® (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference medicines Xgeva ®* (denosumab) and Prolia®* (denosumab) FDA approval based on robust clinical studies and totality of evidence, which show no clinically meaningful differences from reference medicines Basel, March 5, 2024 (Korea Bizwire) – Sandoz, the global leader in generic and biosimilar medicines, [...]

S. Korean Coronavirus Test Kit Firms Earn U.S. FDA Pre-approval

SEOUL, March 29 (Korea Bizwire) — Three South Korean COVID-19 test-kit companies have obtained preliminary approval from the U.S. Food and Drug Administration (FDA), the foreign ministry said Saturday. The initial FDA approval will allow the Korean test-kit makers to sell the products in the United States, where the number of confirmed coronavirus cases has [...]

SK Biopharm’s Anti-epileptic Drug Wins FDA Approval

SEOUL, Nov. 22 (Korea Bizwire) — SK Biopharmaceuticals Co., a biopharmaceutical affiliate of South Korea’s SK Group, said Friday its anti-epileptic drug has won approval from the U.S. Food and Drug Administration (FDA). SK Biopharmaceuticals said the FDA granted approval of XCOPRI, or cenobamate tablets, for the treatment of partial-onset seizures in adults. This is [...]