The FDA has approved Priovant Therapeutics' brepocitinib, to be marketed as Lisraya, a once-daily pill for adults with dermatomyositis, making it the first targeted therapy approved in the disease. The approval rests on the phase 3 Valor trial of 241 patients, where the high dose achieved a mean Total Improvement Score of 46.5 versus 31.2 for placebo, with 55% of treated patients reaching moderate or better improvement with minimal or no steroid use versus 30% on placebo. The Roivant-backed company, formed in 2022 with a Pfizer deal, is also testing the dual TYK2/JAK1 inhibitor in phase 3 noninfectious uveitis and cutaneous sarcoidosis.
The FDA has approved Priovant Therapeutics' Lisraya (brepocitinib) tablets, the first oral treatment indicated for dermatomyositis in adults. The once-daily JAK/TYK2 inhibitor was supported by a phase 3 placebo-controlled study of 241 adults, in which the 30 mg dose produced a higher average Total Improvement Score at week 52 and allowed more patients to cut corticosteroid use. It carries a boxed warning for serious infections, mortality, malignancies, cardiovascular events and thrombosis, and was granted Orphan Drug and Priority Review designations.
The FDA approved Revolution Medicines' daraxonrasib (RMC-6236, brand name Rasonque) on August 26 for patients with metastatic pancreatic cancer who have received at least one prior systemic therapy or are not suited to multiple systemic therapies. The oral RAS(ON) multi-selective non-covalent inhibitor blocks interactions between wild-type and mutant RAS(ON) proteins and downstream effectors, and the FDA said the approval came 6.5 months ahead of schedule.
The US FDA has approved Revolution Medicines' pan-RAS inhibitor daraxonrasib, brand name Rasonque, for previously treated metastatic pancreatic cancer (PDAC). The drug, the company's lead pipeline asset and the first RAS(ON) inhibitor approved worldwide, is active against G12, G13, Q61 and wild-type RAS. Late-stage trials are already underway in first-line, second-line and adjuvant pancreatic cancer settings.
China's National Medical Products Administration has approved Johnson & Johnson's oral IL-23 receptor antagonist icotrokinra (brand name Aiteya) for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy, and for pediatric patients aged 12 and older weighing at least 40 kg. Icotrokinra is described as the first and only targeted oral peptide that precisely blocks the IL-23 receptor.
The FDA approved Revolution Medicines' Rasonque (daraxonrasib), the first RAS(ON) inhibitor to reach the market, on August 26, months ahead of expectation. The once-daily tablet targets multiple forms of RAS protein, a key driver of tumor growth in most pancreatic cancer patients, and offers a new treatment option for the most common form of advanced pancreatic cancer, which arises from cells lining the pancreatic ducts.
The FDA approved Revolution Medicines' first-in-class RAS inhibitor Rasonque (daraxonrasib) on August 26 for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are not suited for multi-drug systemic treatment. It is the first RAS-targeted therapy for the most common type of pancreatic cancer. The drug was reviewed under the FDA commissioner's national priority voucher pilot programme, and approval came one month after the application was accepted, 6.5 months ahead of the PDUFA goal date.
The US FDA has approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic adenocarcinoma patients who have received at least one prior systemic therapy or are not eligible for multiagent systemic therapy. It is the first broadly active RAS-targeted inhibitor to reach market, unlike the KRAS G12C-specific inhibitors sotorasib (Lumakras) and adagrasib (Krazati), which are approved only in NSCLC and colorectal cancer subsets.
FDA approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic ductal adenocarcinoma, making it the first targeted therapy in the new RAS(ON) inhibitor class and the first new cancer drug cleared under the commissioner's national priority review voucher initiative. Revolution Medicines (NASDAQ:RVMD) is launching the drug immediately at a WAC of $39,800 for a 30-day supply.
The FDA approved daraxonrasib, brand name Rasonque, from Revolution Medicines as a second-line treatment for advanced pancreatic cancer, making it the first drug to attack a genetic cause of the disease. In the supporting trial, patients on Rasonque achieved median overall survival of 13.2 months versus 6.7 months on standard chemotherapy. Clinicians described it as the biggest development in pancreatic cancer in decades.
The US FDA approved a new indication for tislelizumab on August 26, 2026, combining it with zanidatamab plus chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The approval covers patients regardless of PD-L1 expression and is the first approved regimen pairing a HER2 bispecific antibody with a PD-1 inhibitor. It rests on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented orally at the 2026 ASCO annual meeting.
Roche announced on August 24, 2026 that the Elecsys pTau217 blood test, developed with Eli Lilly, has received FDA 510(k) clearance for adults aged 55 and older with signs of cognitive decline. It aids assessment of Alzheimer's disease-related amyloid pathology and is the first FDA-cleared single-biomarker Alzheimer's blood test usable both to rule in and rule out amyloid pathology.
On August 25, the FDA approved zanidatamab (Ziihera) combined with tislelizumab (Tevimbra) and chemotherapy for first-line treatment of HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma. The FDA also approved zanidatamab plus chemotherapy without a PD-1 inhibitor for the same indication in HER2 IHC 3+ patients. This is the first approved HER2 bispecific plus PD-1 antibody combination worldwide, developed by BeiGene.
China's NMPA has approved Novartis's radioligand therapy Pluvicto (lutetium vipivotide tetraxetan injection) on August 26, 2026, combined with an androgen receptor pathway inhibitor, for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval extends Pluvicto's use in China from metastatic castration-resistant prostate cancer into the earlier mHSPC setting.
On August 13, 2026, the FDA granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide) combined with subcutaneous daratumumab and dexamethasone for multiple myeloma patients who received at least one prior line of therapy including a proteasome inhibitor and an immunomodulator. Zenbexus is the first cereblon E3 ligase modulator (CELMoD) approved by the FDA. The decision is also the FDA's first approval in relapsed or refractory multiple myeloma based on minimal residual disease (MRD)-negative complete response rather than progression-free survival.
The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.
BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.
The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.
China's NMPA has approved Novartis' radioligand therapy Paiveituo (lutetium-177 teruxvipitide injection) combined with androgen receptor pathway inhibitors for adults with PSMA-positive metastatic hormone-sensitive prostate cancer. The decision on August 25, 2026, follows two mCRPC approvals in China on November 5, 2025, and US FDA approval for the same mHSPC combination on July 31, 2026.
Japan approved GSK's antisense oligonucleotide bepirovirsen (brand name Hibsago) on August 24, 2026 for functional cure of chronic hepatitis B in adults previously treated with nucleos(t)ide analogues who have HBsAg levels of 3000 IU/mL or below. It is the first approved functional cure therapy for hepatitis B worldwide, moving treatment from lifelong viral suppression toward finite-course cure. China has an estimated 75 million people living with hepatitis B infection.