After encouraging early data were released, the FDA granted breakthrough therapy designation to olomorasib, an oral KRAS G12C inhibitor, for the treatment of previously treated advanced pancreatic cancer.
The FDA's Molecular and Clinical Genetics Panel will meet Sept. 23, 2026, to evaluate GRAIL's premarket approval application for the Galleri MCED test.
The complete response letter did not cite any clinical issues regarding the NDA for 177Lu-edotreotide for GEP-NETs.
The FDA has granted breakthrough device designation to Freenome's SimpleScreen Lung, an investigational blood-based test for high-risk lung cancer screening.
The iberdomide-daratumumab-dexamethasone regimen was approved based on superior MRD negativity rate vs standard of care in relapsed/refractory multiple myeloma.
FDA reviews OST-HER2 survival data for potential accelerated approval for preventing recurrent metastatic osteosarcoma after lung surgery.
UGN-103 NDA targets recurrent low-grade NMIBC; phase 3 UTOPIA reports 77.8% complete response and 94.5% 6-month durability.
The designation is for sapanisertib/serabelisib (Piktor) plus chemo in patients who have progressed after chemo and an immune checkpoint inhibitor.
The FDA has granted fast track designation to ETX-19477, an oral PARG inhibitor, for BRCA-mutated, HR+/HER2– unresectable or metastatic breast cancer.
The FDA has granted fast track designation to BH-30643, an oral OMNI-EGFR inhibitor, for advanced EGFR C797S-positive non–small cell lung cancer after a third-generation TKI.
The FDA has granted fast track designation to PLN-101095 plus pembrolizumab for ICI-refractory advanced or metastatic solid tumors.
The FDA has granted fast track designation to safusidenib, an oral IDH1 inhibitor, based on durable phase 2 J201 study responses in IDH1-mutant glioma.
The sBLA for dostarlimab in dMMR/MSI-H rectal cancer is based on the AZUR-1 trial.
The FDA approved 2 zanidatamab-based regimens for first-line HER2-positive gastroesophageal adenocarcinoma, based on phase 3 HERIZON-GEA-01 data.
FDA issues third CRL for lower-dose dasatinib Dasynoc over manufacturing, not data, as Xspray races to resubmit amid PPI absorption benefits.
The approval of daraxonrasib in pancreatic cancer is supported by results from the phase 3 RASolute 302 trial.
The LRRC15-targeting antibody-drug conjugate will be investigated in a first-in-human trial later this year.
The assays are now approved to assess HER2 status in gastric, gastroesophageal junction, and esophageal adenocarcinoma.
ERAS-0015 is being tested in AURORAS-1, an open-label study enrolling patients with RAS-mutant solid tumors.
Celcuity seeks FDA expansion for gedatolisib combos in PIK3CA-mutant HR+/HER2– metastatic breast cancer, after VIKTORIA-1 shows longer PFS than alpelisib.
Varsetatug masetecan is a first-in-class ADC that pairs a monoclonal antibody against EpCAM with a topoisomerase 1 inhibitor payload.
Shubham Pant, MD, MBBS, explains the significance of the FDA approval of daraxonrasib for mPDAC.
FDA clears IND for ADI-212, an off-the-shelf PSMA-targeted gamma-delta CAR T for metastatic castration-resistant prostate cancer, as phase 1/2 trial readies 2026 enrollment.
The approval is primarily supported by the phase 3 VERIFY study.
The approval marks the first new agent specifically approved for essential thrombocythemia in the US in nearly 30 years.