Camurus’s FDA review restart for Oclaiz puts long-acting octreotide on track for a potential U.S. launch in mid-2026

Camurus’s FDA review restart for Oclaiz puts long-acting octreotide on track for a potential U.S. launch in mid-2026

Camurus AB announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application for Oclaiz (CAM2029), an extended-release octreotide injection for acromegaly. The agency assigned a Prescription Drug User Fee Act (PDUFA) action date of June 10, 2026, reinitiating regulatory review after an earlier Complete Response Letter related […]

J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

Johnson & Johnson (J&J) has reported updated results from its Phase 1b/2 OrigAMI-1 trial evaluating amivantamab-vmjw in combination with chemotherapy for patients with RAS/BRAF wild-type metastatic colorectal cancer. The bispecific antibody, which targets epidermal growth factor receptor (EGFR) and MET, achieved confirmed response rates of 73 percent in the first-line setting and 44 percent in […]

1 51 52 53 54 55 72