The U.S. Food and Drug Administration (FDA) has determined that the inspection findings behind its rejection of HLB’s liver cancer drug Rivoceranib can be addressed through voluntary corrective actions, easing market concerns over the treatment. HLB said Wednesday that its U.S. subsidiary Elevar Therapeutics has received a close-out letter regarding the FDA’s current good manufacturing practice (cGMP) inspection of a facility operated by its Chinese partner Jiangsu Hengrui Pharmaceuticals that produces the drug substance for Rivoceranib. In the letter, the FDA said the facility was generally in compliance with cGMP requirements and classified the inspection findings as Voluntary Action Indicated (VAI). VAI is an inspection classification indicating that the FDA identified issues at a facility but did not consider them serious enough to force regulatory action. HLB said the letter also stated that the VAI classification itself would not affect the FDA’s review of the pending application related with the facility. HLB has received three Complete Response Letters (CRLs) from the FDA regardi
HLB resolves issues behind FDA setback for novel liver cancer drug
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K-pop girl group RESCENE will take to the stage during an upcoming high-profile football match in the 2026 Coupang Play Series. Coupang Play on Wednesday announced RESCENE’s performance during the half-time show for the 2026 Coupang Series’ Manchester City vs Atlético Madrid match, set to take place at Seoul World Cup Stadium on Aug. 9. RESCENE, consisting of members Woni,… Read more: RESCENE named half-time performers for upcoming Man City vs. AT Madrid match - Foreign investment in Korean companies jumps 30% in a yearForeign investment in listed companies here surged by about 30 percent over the past year, led largely by U.S. asset managers and investment funds. Cosmetics, semiconductors and biotechnology attracted particularly strong interest, data showed Wednesday. According to CEO Score, a corporate research firm, foreign companies and funds held stakes of at least 5 percent in 123 of Korea’s 500 largest… Read more: Foreign investment in Korean companies jumps 30% in a year
- HLB resolves issues behind FDA setback for novel liver cancer drugThe U.S. Food and Drug Administration (FDA) has determined that the inspection findings behind its rejection of HLB’s liver cancer drug Rivoceranib can be addressed through voluntary corrective actions, easing market concerns over the treatment. HLB said Wednesday that its U.S. subsidiary Elevar Therapeutics has received a close-out letter regarding the FDA’s current good manufacturing practice (cGMP) inspection of a… Read more: HLB resolves issues behind FDA setback for novel liver cancer drug
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Latest Entertainment from Korea
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Learn People & History of Korea
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