Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.
The company on Thursday said it now expects more than $10 billion in new product sales in 2026, despite previously forecasting $10 billion to $13 billion in 2025.
The regulator lifted a clinical hold on Verve Therapeutics’ CRISPR-based therapy clearing its Investigational New Drug application and plans to evaluate VERVE-101 in a Phase I heterozygous familial hypercholesterolemia trial.
The company’s experimental lgG4 antibody met the primary endpoint in a late-stage study of the rare skin disease. AnaptysBio will submit an application to the FDA by the third quarter of 2024.
On Monday, Syndax Pharmaceuticals announced that its menin inhibitor revumenib met the goal in a pivotal leukemia study and stopped the trial early. Their stock price still dropped on the news.
Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
Eli Lilly has filed lawsuits in several states seeking to prevent unauthorized selling of products that claim to contain tirzepatide, the active ingredient in its blockbuster type 2 diabetes drug Mounjaro.
The biopharma’s acute myeloid leukemia hopeful is on partial clinical hold, affecting two Phase III AML studies, Gilead announced Monday. The CD47 candidate also spent four months on hold in 2022.
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
