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.
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 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.
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.
The FDA has approved Johnson & Johnson's IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia (wAIHA), a rare, life-threatening autoantibody disease, in adults and pediatric patients aged 12 and older who currently or previously received corticosteroids. Announced on August 24, 2026, the approval covers a condition in which pathogenic IgG autoantibodies destroy red blood cells, causing severe anemia and fatigue.
The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib targets Ras in a disease setting with limited options.
FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The approval is based on clinical data that drew a standing ovation at the American Society of Clinical Oncology (ASCO) annual meeting in May.
The FDA approved Revolution Medicines' Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a 500-patient randomized trial, Rasonque improved median overall survival to 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the user fee deadline, under Breakthrough Therapy, Orphan Drug and Priority Review designations and the National Priority Voucher pilot program.
Why it matters: First-in-class RAS inhibitor approval gives a survival benefit in metastatic pancreatic adenocarcinoma, a high-mortality cancer with few options.
The FDA authorized Abbott Diabetes Care's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes, making it the first wearable device in the U.S. to continuously monitor ketones and the first worldwide to track both ketones and glucose together. It measures interstitial fluid every minute over a 10-day wear period, sends readings to a smartphone and can alert users when ketones reach concerning thresholds before diabetic ketoacidosis becomes an emergency. Authorization, granted through the De Novo pathway after Breakthrough Device designation, rests on six clinical studies enrolling more than 600 participants.
FDA approved orforglipron just 50 days after its NDA submission, making it the first new molecular entity cleared under the FDA's National Priority Voucher program and the fastest NME approval since 2002. In a late-stage trial, patients taking one highest-dose tablet daily lost an average of 27.3 pounds, or 12.4% of body weight, over 72 weeks. It is not the first oral GLP-1 weight-loss drug, as Novo Nordisk's oral Wegovy (semaglutide) was approved in December 2015.
