July 2026 Brief

FDA issues Complete Response Letter for manganese chloride tetrahydrate (Orviglance), an oral liver MRI contrast agent for renal-impaired patients.

The FDA set a PDUFA date of April 28, 2027 for approval of the gamma secretase inhibitor for progressing desmoid tumors.

FDA clears IND for UGN-501 oncolytic virus, launching phase 1 NMIBC trial to test intravesical safety and immune-driven tumor control.

Pegfilgrastim-pccg now carries the same indications as its reference product, Neulasta.

The FDA approval was based on studies using an on-body injector to administer isatuximab easily.

FDA clears perioperative pembrolizumab plus enfortumab vedotin for muscle-invasive bladder cancer, boosting event-free and overall survival ahead of cystectomy.

This is the third complete response letter the FDA has issued for rivoceranib plus camrelizumab for hepatocellular carcinoma.

The FDA will review the CELMoD mezigdomide in combination with carfilzomib, and dexamethasone based on the SUCCESSOR-2 trial.

FDA gives full approval to selpercatinib for RET fusion solid tumors, backed by 47% response rate and long-lasting benefit across cancers.

Phase 3 VIKTORIA-1 results show that gedatolisib combinations extend progression-free survival in PIK3CA-mutated breast cancer, with strong response rates and manageable stomatitis.

The designation for pelareorep was supported by results from the phase 1/2 GOBLET study.

The NDA for daraxonrasib in PDAC is supported by results from the phase 3 RASolute 302 trial.

FDA clears zidesamtinib for previously treated ROS1-positive metastatic NSCLC, showing 44% responses, CNS activity, and manageable safety in ARROS-1 trial.

The FDA will review the PARP inhibitor/androgen pathway receptor inhibitor combination in metastatic castration-sensitive prostate cancer in the fourth quarter of 2026.

FDA fast-tracks ISM6331 for hard-to-treat pleural mesothelioma, spotlighting Hippo pathway targeting and early phase 1 results presented at ESMO 2026.

The sBLA for subcutaneous amivantamab is supported by results from the phase 1b/2 OrigAMI-4 study.

FDA advisers back RP1 plus nivolumab for anti–PD-1–refractory advanced melanoma, citing durable responses despite design concerns and awaiting confirmatory IGNYTE-3 data.

FDA orphan designation boosts enzomenib for ALL, as menin inhibitor trials show early responses and tolerable safety in relapsed leukemia.

FDA tentatively OKs cabozantinib capsules for RCC, HCC and epNET, with dose-conversion guidance, error warning and improved absorption.

The FDA approved vusolimogene oderparepvec-wtpg plus nivolumab for PD-1–refractory advanced melanoma after a 10-3 advisory vote in favor of the oncolytic therapy.