Drugs

Elevar/Hengrui Resubmission Accepted for Liver Cancer Therapy

FDA has accepted for review an Elevar Therapeutics and Hengrui Pharmaceuticals resubmission for rivoceranib plus camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma. The agency has set a user fee review action date of 4/9/2027.

On 10/9, Elevar resubmitted the NDA for rivoceranib, while Hengrui Pharma resubmitted a BLA for camrelizumab. The agency will review the applications under an integrated review process for the two-drug combination regimen, according to the companies.

The companies’ resubmission marks the fourth attempt to win U.S. approval, and follows three previous complete response letters (CRLs) issued in 5/2024, 5/2025 and 7/2026. The most recent rejection cited GMP deficiencies at a manufacturing facility, rather than concerns about the treatment's clinical efficacy or safety, according to the companies.

Media reports indicate that FDA recently classified inspections of the relevant manufacturing facilities as Voluntary Action Indicated, and the companies believe they have addressed the manufacturing deficiencies identified in the latest CRL.

The application is supported by the global Phase 3 CARES-310 trial, in which the combination achieved a median overall survival of 23.8 months, compared with 15.2 months for sorafenib. The treatment reduced the risk of death by 36%, according to the companies.

Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

Merck's investigational GLP-1/glucagon receptor dual agonist efinopegdutide (MK-6024) demonstrated higher rates of MASH resolution and liver fibrosis improvement than placebo in a Phase 2b trial involving patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis. The results, presented at the American Association

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

FDA officials say drug manufacturers may be able to establish dosing recommendations and characterize drug-drug interaction risks without conducting additional clinical studies, including through pharmacokinetic modeling and real-world data, provided the evidence is scientifically justified. During a series of FDA presentations released 11/4 on [Drug Interaction Information

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

FDA has granted Janssen Biotech accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) and its use in treating adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. “HNSCC is an aggressive, life-threatening disease

Significantly More Unannounced Foreign Inspections

FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+

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Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

Significantly More Unannounced Foreign Inspections