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Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma

BioLineRx Reports First Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

/PRNewswire/ BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today reported its unaudited.

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

20.05.2023 - 12 of 16 voting-eligible advisors vote “no” (with two abstentions) on question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” 15 of 16 voting-eligible . Seite 1

FDA Committee Votes Against Risk-Benefit Profile of OCA 25 mg for NASH

The June 22, 2023 PDUFA date for obeticholic acid 25 mg oral tablets for the treatment of precirrhotic liver fibrosis appears to be in jeopardy after a May 23, 2023 meeting of the FDA's Gastrointestinal Drugs Advisory Committee.

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH