{
  "id": 18054890,
  "title": "HLB Liver Cancer Drug Re-enters FDA Review, With Decision Due April 9",
  "url": "https://urgent.news/2026/11/04/hlb-liver-cancer-drug-re-enters-fda-review-with-decision-due-april-9",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-11-04T02:28:51.000Z",
  "source": {
    "name": "BusinessKorea",
    "slug": "businesskorea",
    "url": "https://www.businesskorea.co.kr/news/articleView.html?idxno=280420"
  },
  "original_language": "en",
  "account": null,
  "summary": "HLB's liver cancer drug candidate, rivoceranib combined with immunotherapy drug camrelizumab, has re-entered the FDA's review process, with a decision due on April 9, 2027. The combination therapy, which showed a 36% reduction in risk of death and longer median progression-free survival in a Phase 3 trial, was resubmitted following three previous Complete Response Letters. The FDA has classified the resubmission as Class 2, which typically takes six months to review, longer than the company had hoped. The shorter-than-anticipated timeline could have led to an approval decision before the end of 2026, had the application been classified as Class 1. The news of the longer review period caused HLB shares to drop significantly on the KOSDAQ market.",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 2,
    "also_reported_by": [
      {
        "outlet": "The Korea Times",
        "title": "HLB liver cancer drug enters FDA review, decision expected by April",
        "url": "https://urgent.news/2026/11/04/hlb-liver-cancer-drug-enters-fda-review-decision-expected-by-april",
        "published": "2026-11-04T02:57:02.000Z"
      }
    ]
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}