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Regulatory approval expands targeted therapy in CLL
The FDA has approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have del(17p), using data from...
Pneumococcal vaccine Phase 3 success pressures incumbents
Vaxcyte reported that its 31-valent pneumococcal conjugate vaccine, VAX-31, met primary endpoints in a Phase 3 trial in adults, triggering a sharp stock reaction and raising the stakes in the...
CAR-T and transplant therapy-associated blood cancer risk characterization
A systematic review is refining how therapy-related myeloid neoplasms emerge after CAR-T versus autologous stem cell transplantation. Across nine included studies, therapy-related myeloid...
Health systems and commercialization: AI/real-world data validate early breast cancer immunotherapy
Real-world evidence in Tokyo is confirming that pembrolizumab combined with chemotherapy before and after surgery delivers event-free survival rates in line with the landmark KEYNOTE-522 trial for...
Rare disease M&A and platform moves: Shionogi expands with IntraBio
Shionogi is moving further into rare diseases by agreeing to acquire IntraBio for $2 billion upfront, adding a commercial treatment and strengthening a pipeline that includes therapies for...
Manufacturing and regulatory process: FDA pauses hemophilia A drug review
The FDA has delayed Novo’s review of denecimig, a hemophilia A injection, citing facility issues discovered during a pre-license inspection. The agency extended its timeline because of ongoing...
Clinical pipeline and oncology: MRI-backed monitoring of early disease progression in breast cancer trials
A new global Phase 3 trial, AFT-70 NAVIGATE, is set to test whether ultrasensitive Signatera circulating tumor DNA (molecular residual disease, MRD) monitoring can guide safer use of CDK4/6...
Diagnostics innovation: contrast-enhanced ultrasound expands lung cancer biopsy options
A retrospective study suggests contrast-enhanced ultrasound (CEUS) can guide lung cancer biopsies when bronchoscopy fails or tumors are hidden within collapsed lung tissue. In 32 patients, CEUS...
FDA and trial administration: streamlined IND pathway pilot aims to accelerate first-in-human starts
The FDA has rolled out an expedited Investigational New Drug (IND) pilot program intended to reduce bottlenecks in the early process of getting therapies into clinical trials. The IND pilot is...
Imaging-guided precision in urology: PSMA PET/CT biopsy detects clinically significant disease missed by MRI
A prospective study reports that PSMA PET/CT-guided targeted biopsy finds clinically significant prostate cancer in 37% of men with negative or inconclusive MRI results—nearly doubling detection...
FDA decision expands frontline CLL treatment
The FDA approved Eli Lilly’s pirtobrutinib (Jaypirca) for adults with previously untreated CLL or SLL who do not have del(17p), moving the noncovalent BTK inhibitor into first-line care. The...
Rare-disease M&A accelerates with Shionogi IntraBio deal
Shionogi agreed to acquire IntraBio for $2 billion upfront, adding Aqneursa, a drug approved for two rare neurological disorders, to its expanding rare-disease portfolio. The deal also positions...
Pneumococcal vaccine Phase 3 success sets up competitive pressure
Vaxcyte said its next-generation pneumococcal vaccine, VAX-31, met key endpoints in a Phase 3 trial in adults, triggering a sharp stock reaction. The candidate is designed to cover 31 pneumococcal...
Immune engineering guidance updates for severe autoimmune CAR T use
An international expert panel published updated 2026 consensus recommendations on the safe use of CAR T-cell therapy for severe, treatment-refractory autoimmune disease in The Lancet Rheumatology....
New clinical imaging approach for follow-up after aneurysm rupture
A new systematic review of 20 studies involving more than 11,000 patients found that early repair of ruptured brain aneurysms reduces rebleeding risk after subarachnoid hemorrhage. However,...
AI validation in therapeutics: nerve stimulation modeling open-source
Researchers released golgi, an open-source platform that automates nerve stimulation modeling end-to-end, from segmented nerve images to fiber recruitment predictions. The workflow is validated...
Gene therapy hearing milestone highlights ongoing AAV progress
A review charts the rapid growth of AAV-mediated OTOF gene replacement therapy for congenital deafness, spanning early human trials through the first FDA approval in the indication. The synthesis...
Regulatory accelerant: FDA launches expedited IND pilot for bottlenecks
The FDA rolled out an expedited pilot program aimed at reducing bottlenecks in investigational new drug (IND) applications as part of the HHS initiative “Operation TrialBlazer.” The pilot is...
Company exit: Genentech’s global AI drug discovery head leaves
Genentech’s global head of AI for drug discovery, Richard Bonneau, exited the company, according to reporting. The departure follows other high-profile partnership churn at large pharma and...
Funding: Sensible Bio raises to build mRNA manufacturing platform
Sensible Biotechnologies raised $47 million in a Series A to develop an mRNA therapy manufacturing platform. The company’s pitch focuses on a manufacturing approach designed to increase...