The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.

Original title: “Trailing rivals, AbbVie scores win with dual-acting myeloma drug”

Zanvastro is now the first approved medicine for Alexander disease. Elsewhere, an immune system specialist posted positive results and a cell therapy developer turned to layoffs.

Original title: “Ionis’ rare neurology drug approved; Pfizer inks an ADC deal”

Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the PRAC meeting 31 August - 3 September 2026Draft Reference Number: EMA/PRAC/164465/2026…, PRAC statistics: September 2026 Monthly figures for PRAC outcomes based on the draft agenda. @ European Medicines Agency,

Original title: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026”

AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets.

Original title: “AbbVie’s T cell engager delivers survival benefit in Phase 3 multiple myeloma study”

A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the…, This situation shows the complexity of shortages and how coordination between the European Commission, EU Member States, MSSG and SPOC Working Party can ensure fair…, Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availabil

Original title: “New EU supply chain to end Visudyne shortage”

The sponsor is Jonsson Comprehensive ... a rare, metabolically defined hereditary cancer syndrome. For advanced HLRCC kidney cancer, today’s care often uses VEGF/EGFR-directed therapy (commonly bevacizumab + erlotinib) and/or clinical trials rather than classic clear-cell RCC standards alone, while symptomatic cutaneous/uterine leiomyomas are typically managed with procedures and symptom-directed medications—this trial tests whether systemic 6‑MP can modify multiple disease manifestations ... The sponsor is Jonsson Comprehensive Cancer Center (UCLA); commercially, 6‑MP is a long-approved generic (historically associated with brands such as Purinethol), so the angle is repurposing a well-known oral antimetabolite against a rare, metabolically defined hereditary cancer syndrome. For advanced HLRCC kidney cancer, today’s care often uses VEGF/EGFR-directed therapy (commonly bevacizumab + erlotinib) and/or clinical trials rather than classic clear-cell RCC standards alone, while symptomatic cutaneous/uterine leiomyomas are typically managed with procedures and symptom-directed medications—this trial tests whether systemic 6‑MP can modify multiple disease manifestations in a genotype-selected population. An 85% complete-response rate stands out in high-risk lymphoma, and a KRAS G12C triplet reaches 56.5% ORR—plus 24 new trials. For mCRPC after progression on androgen receptor pathway inhibitors, current care is sequential systemic therapy (taxane chemotherapy, ARPI switching in select cases, PARP inhibitors for HRR-altered disease, radioligand therapy such as lutetium‑177–PSMA‑617 for eligible patients, and bone-targeted agents), while sipuleucel‑T is typically used earlier in asymptomatic/minimally symptomatic disease and has limited direct tumor-shrinkage—this trial asks whether cytokine augmentation can make the immune response more clinically meaningful. The key angle is “spare-adjuvant” de-escalation: today’s care for high-risk resectable stage III/limited stage IV melanoma commonly includes surgery plus prolonged adjuvant PD‑1 (or, for BRAF V600–mutant disease, adjuvant BRAF/MEK targeted therapy), and this trial tests whether an abbreviated pre-op immunotherapy-only approach can preserve survival while reducing treatment duration and toxicity burden.

Original title: “New in Oncology - September 3, 2026”

The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar

Original title: “FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats”

The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.

Original title: “RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer”

A new data cut of a trial pitting ivonescimab, a bispecific antibody, against Merck’s Keytruda showed the new drug helped people live longer.

Original title: “Akeso, Summit cancer drug confirms lung cancer survival benefit”

The success of apazunersen in a Phase 3 trial for Angelman syndrome was a key driver of Ultragenyx’s value, according to William Blair, and the asset’s failure robs the biotech of any meaningful near-term milestones.

Original title: “Ultragenyx’s 'high-risk' Angelman bet fails, cratering stock and forcing strategic review”

Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial ... Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. The trial evaluated the safety and efficacy of once-daily doses of RASONQUE 300 mg or less in 136 patients with second-line or later NSCLC with tumors carrying diverse RAS mutations other than RAS G12C, and whose disease had progressed following, or who were intolerant to, platinum-based chemotherapy and anti-PD-(L)1 therapy. RASONQUE demonstrated dose-dependent antitumor activity and exhibited a manageable safety profile in the Phase 1/2 trial. Within the 160 mg to 220 mg dose group, a subgroup of 38 docetaxel-naïve patients had previously received first- or second-line platinum-based chemotherapy and anti-PD-(L)1 therapy. In this subgroup, the confirmed objective response rate was 42% (95% confidence interval [CI], 26%-59%) and a disease control rate of 89% (95% CI, 75%-97%). RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. IMPORTANT SAFETY INFORMATION FOR U.S. APPROVED INDICATION · RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.

Original title: “New England Journal of Medicine Publishes Phase 1/2 Clinical Data on Revolution Medicines’ RASONQUE™ (daraxonrasib) in Metastatic Non-Small Cell Lung Cancer - BioSpace”

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy ... The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value. Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay. Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. The 38-patient subgroup had median overall survival of 16.0 months; the global, randomized Phase 3 RASolve 301 trial in NSCLC is ongoing.

Original title: “An experimental lung cancer drug held disease in check for 89% of patients in one group.”