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.
China has approved BeiGene's regimen combining a HER2 bispecific antibody with a PD-1 inhibitor for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, regardless of patients' PD-L1 expression status. The article calls it the first and only immuno-oncology combination in that first-line setting to achieve a median overall survival of more than two years. A marketing application for the indication had already been filed in China.
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.
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 now becomes an FDA-approved option for patients with this indication.
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.
Japan's Ministry of Health, Labour and Welfare has approved GSK's antisense oligonucleotide therapy Hibsago (bepirovirsen) as a functional cure treatment for chronic hepatitis B, the first such regimen in Japan. It applies to adults previously treated with nucleos(t)ide analogues for at least 6 months who meet predefined virological marker criteria.
Japan's Ministry of Health, Labour and Welfare approved GSK's antisense oligonucleotide bepirovirsen (brand name Hibsago) on August 24, 2026, as a functional cure for chronic hepatitis B. It is the first approval worldwide for the drug and the first approved functional cure therapy for CHB, covering adults previously treated with nucleos(t)ide analogues for at least six months who meet viral marker criteria. The disease affects about 240 million people globally, including about 75 million in China.
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.
The FDA approved Johnson & Johnson's FcRn blocker IMAAVY (nipocalimab-aahu) on August 24 for warm autoimmune hemolytic anemia (wAIHA) in adults and children aged 12 and older. It is the first therapy approved specifically for wAIHA, a disease in which pathogenic IgG autoantibodies destroy red blood cells, causing severe anemia, extreme fatigue and significant morbidity and mortality risk. The report forecasts annual sales exceeding $5 billion.
The FDA granted accelerated approval to Ultragenyx Pharmaceutical's AAV gene therapy Genglycos (pariglasgene brecaparvovec-opnr, DTX401) for adults and children aged 8 and older with glycogen storage disease type Ia (GSDIa). GSDIa is an ultra-rare inherited metabolic disorder caused by G6PC gene mutations leading to glucose-6-phosphatase deficiency. It is the second AAV drug the FDA has approved recently.
The FDA has approved Johnson & Johnson's IMAAVY (nipocalimab-aahu) for warm antibody autoimmune hemolytic anemia in adults and children aged 12 and older who are receiving or have previously received corticosteroid treatment, an announcement made on August 24. wAIHA is a rare, life-threatening disease in which pathogenic IgG autoantibodies attach to and destroy red blood cells, causing severe anemia, extreme fatigue and increased morbidity and mortality risk.
Johnson & Johnson's FcRn-targeting monoclonal antibody nipocalimab (IMAAVY) received FDA approval on August 24 for warm autoimmune hemolytic anemia in adults and children aged 12 and older who have received glucocorticoid therapy before or currently. Nipocalimab selectively blocks FcRn to reduce circulating IgG antibodies, including pathogenic autoantibodies. Johnson & Johnson obtained the drug through its $6.5 billion acquisition of Momenta in August 2020.
The FDA has expanded the label for Johnson & Johnson's monoclonal antibody Imaavy to include warm autoimmune hemolytic anemia, a rare disorder that destroys red blood cells. The approval comes sixteen months after Imaavy's initial FDA approval.
GSK's antisense oligonucleotide drug bepirovirsen (Hibsago) has been approved in Japan for adults with chronic hepatitis B who received at least six months of nucleos(t)ide analogue therapy and met predefined virological criteria, aiming at functional cure. The approval is based on the Phase III B-Well study. Marketing applications are under review in China, the US and the EU.
GSK's bepirovirsen (Hibsago) has been approved in Japan as a functional cure for chronic hepatitis B, the first approval for the drug anywhere in the world. It is indicated for adults with hepatitis B who have received at least six months of nucleos(t)ide analogue therapy and meet predefined viral marker criteria. Hepatitis B affects more than 240 million people worldwide when the immune system fails to clear the virus.
Japan's Ministry of Health, Labour and Welfare has approved GSK's antisense oligonucleotide Hibsago (bepirovirsen) for adults with chronic hepatitis B who have received at least six months of nucleos(t)ide analogue therapy and meet predefined virological criteria, to achieve a functional cure. Announced on August 24, this is the drug's first approval anywhere in the world and Japan's only approved functional-cure treatment for chronic hepatitis B.
Japan's Ministry of Health, Labour and Welfare has approved GSK's investigational antisense oligonucleotide drug Hibsago (bepirovirsen) for adults with chronic hepatitis B virus infection, positioning it as a functional cure therapy. Functional cure means HBV DNA and hepatitis B surface antigen remain undetectable for at least 24 consecutive weeks after stopping all treatment. GSK announced the approval on August 24.
Japan's Ministry of Health, Labour and Welfare has approved Takeda's oral drug ORZEYFUL (oveporexton) for adults with type 1 narcolepsy, announced on August 24. The drug is Takeda's self-developed first-in-class oral orexin receptor 2 (OX2R) agonist and the only approval in Japan addressing the underlying biology of the disease, orexin deficiency, rather than individual symptoms. It is ORZEYFUL's third regulatory approval worldwide.
GSK's antisense oligonucleotide Bepirovirsen, licensed from Ionis, has been approved in Japan as a functional cure for chronic hepatitis B. It applies to adults with CHB infection who have received at least six months of nucleos(t)ide analogue therapy and meet viral marker criteria. The drug suppresses hepatitis B virus DNA replication, lowers HBsAg levels and stimulates a durable immune response. GSK filed for approval in China in May.