Approval in adults aged 50 through 64 years was based on a randomized, observer-blind, active-controlled phase 3 trial (NCT06602024) that enrolled 40,805 adults aged 50 years and older across 11 countries. The study evaluated safety and reactogenicity and relative vaccine efficacy compared with a standard-dose active comparator against reverse transcription polymerase chain reaction–confirmed, protocol-defined influenza-like illness caused by influenza A or B strains. Accelerated approval in adults aged 65 years and older was based on a randomized, observer-blind, active-controlled trial (NCT05827978) involving 2,992 US adults aged 65 years and older.
August 5
mFLUSIVA
On August 5, 2026, the FDA approved mRNA-1010 (mFLUSIVA, Moderna Inc.) for use in adults aged 50 years and older. The mRNA-based influenza vaccine is indicated for active immunization to prevent influenza disease caused by influenza A subtypes and influenza B types represented in the vaccine. For adults aged 65 years and older, the indication was granted under the accelerated approval pathway based on immune responses.
August 13
Zenbexus
On August 13, 2026, the FDA granted accelerated approval to iberdomide (Zenbexus; Bristol Myers Squibb) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for adults with multiple myeloma who received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. Iberdomide is the first FDA-approved cereblon-modulating protein degrader, or CELMoD, for multiple myeloma.
Approval was supported by the phase 3, multicenter, randomized, open-label EXCALIBER-RRMM trial, which compared iberdomide plus daratumumab, hyaluronidase-fihj, and dexamethasone with daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma.
August 17
Lerochol
On August 17, 2026, the FDA approved an autoinjector version of lerodalcibep-liga 300 mg/1.2 mL (Lerochol, LIB Therapeutics, Inc) and an update to its prescribing information. Lerodalcibep, a PCSK9 inhibitor, is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
FDA approval of lerodalcibep was based on the global phase 3 LIBerate clinical trial program, which enrolled more than 2,900 patients with cardiovascular disease, patients without cardiovascular disease who were at very high or high cardiovascular risk, and patients with heterozygous or homozygous familial hypercholesterolemia.
August 25
Imaavy
On August 25, the FDA approved nipocalimab-aahu (Imaavy, Janssen Biotech, Inc) injection for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 years and older who are currently or were previously treated with corticosteroids. In wAIHA, immunoglobulin G antibodies target red blood cells for destruction, resulting in hemolysis and anemia. The disorder affects approximately 1 to 3 people per 100,000 annually and is the most common type of autoimmune hemolytic anemia.
The approval was based on results from the 24-week, randomized, double-blind, placebo-controlled wAIHA Study (NCT04119050). The trial enrolled 118 patients with a confirmed diagnosis of wAIHA for at least 3 months, hemoglobin levels below 10 g/dL, evidence of active hemolysis, and a positive direct antiglobulin test.
August 26
Rasonque
On August 26, 2026, the FDA approved daraxonrasib (Rasonque, Revolution Medicines, Inc), a RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy. Daraxonrasib is a once-daily tablet that targets multiple forms of RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma. The approval was supported by findings from a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. Daraxonrasib improved median overall survival to 13.2 months compared with 6.7 months among patients who received standard chemotherapy. The FDA granted the therapy Breakthrough Therapy and Orphan Drug designations and Priority Review.
“This drug showed unprecedented results in an area of high unmet need,” Angelo de Claro, MD, director of the FDA’s Oncology Center of Excellence, said in a press release. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”
August 26
Tivicay PD
On August 26, the FDA approved dolutegravir (Tivicay PD; ViiV Healthcare) in combination with other antiretroviral agents to treat HIV infection in newborns from birth to 4 weeks who weigh at least 2 kg. Tivicay and Tivicay PD were already approved for adults and children older than 4 weeks.
The approval was supported by pharmacokinetic modeling and findings from IMPAACT 2023 (NCT05406583). In the study, 48 newborns exposed to HIV-1 who weighed at least 2 kg received dolutegravir from birth for up to 6 weeks alongside standard-of-care antiretroviral medications intended to prevent mother-to-child HIV transmission. Investigators followed the newborns for 16 weeks.