September 2026 Brief

The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify eligible patients for the camizestrant regimen.

The FDA granted accelerated approval to sevabertinib for HER2-mutant, nonsquamous NSCLC regardless of prior systemic therapy, based on SOHO-01 trial data.

The FDA has approved Omcazio, a capsule-based formulation of cabozantinib as a laurylsulfate salt, that demonstrated bioequivalence to the existing tablet.

The FDA will use the extension to review additional data supporting the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.

The FDA approved a label update cutting postinfusion monitoring for the first 2 tarlatamab doses from up to 24 hours down to 6 to 8 hours.

The FDA has approved Pixclara (floretyrosine F 18), the first FET-PET imaging agent for distinguishing recurrent glioma from treatment-related change.

The FDA approved the topical gel with the brand name Ameluz for use with photodynamic therapy for basal cell carcinoma; it is already approved for actinic keratosis.

The approval of lutetium Lu 177 dotatate injection for GEP-NETs is based on results from the ERASMUS study.

New RASolute trials test daraxonrasib for metastatic and resected pancreatic cancer, comparing combos and follow-up use to improve outcomes.

The application for bezuclastinib in advanced systemic mastocytosisis is supported by data from the APEX trial.

The FDA approved an sNDA updating the taletrectinib label with a 49.7-month median duration of response from TRUST-I in ROS1-positive NSCLC.

FDA clears Triton 1 robotic colonoscopy for screening and advanced therapy, backed by first-in-human data showing high detection rates and reduced clinician workload.

The FDA's Expedited Investigational New Drug (IND) Pilot Program pairs trial sponsors and research institutions to promote phase 1 trials in the US.

In the phase 3 EMBER-3 trial, imlunestrant plus abemaciclib doubled median progression-free survival vs imlunestrant alone in ESR1-mutated advanced breast cancer.

The FDA designation is for LYT-200 plus a hypomethylating agent for relapsed/refractory high-risk myelodysplastic syndromes.

The FDA has recommended conducting a new trial showing an OS benefit with tovecimig in biliary cancer before submitting a BLA.

New 177Lu-dotatate radioligand therapy expands options for SSTR+ GEP-NETs, backed by NETTER-1 efficacy and key safety guidance.

The oral FGFR2 inhibitor lirafugratinib is now FDA approved for the second-line treatment of cholangiocarcinoma harboring FGFR2 alterations.

LRRC15-targeting ADC SOT106 gains FDA fast track and orphan status for sarcomas, showing preclinical promise as it heads into a first-in-human trial.

Advisory panel backs Galleri blood test for adults 50+, citing strong specificity, mixed sensitivity, and follow-up impacts as FDA weighs approval.

FDA approves belzutifan plus lenvatinib for advanced clear cell RCC after PD-1/PD-L1 therapy, based on PFS and response rate benefit vs cabozantinib.

Durvalumab plus enfortumab vedotin improved EFS and OS in MIBC and will be considered for FDA approval in the fourth quarter of 2026.

Elinzanetant, already approved for menopause-related VMS, is being considered to address hot flashes associated with adjuvant breast cancer endocrine therapy.

The FDA communicated that the phase 2 IDeate-Lung01 results were not sufficient for an accelerated approval of I-DXd in small cell lung cancer.

The application is supported by the phase 3 SAFFRON trial, in which savolitinib plus osimertinib improved progression-free and overall survival vs chemotherapy.

FDA fast-tracks plinabulin plus docetaxel for post-immunotherapy non-squamous NSCLC, as DUBLIN-4 phase 3 targets survival gains.

Degevma was approved for skeletal-related events in adults with bone metastases, giant cell tumor of bone, and the treatment of hypercalcemia of malignancy.

Resubmitted FDA filing advances off-the-shelf EBV-specific T-cell therapy tab-cel for relapsed EBV+ PTLD after transplant, with longer follow-up.