Scientists report progress in malaria vaccine development with new antibody-targeting approaches, while separate research reveals increasingly sophisticated drug resistance in malaria parasites. Meanwhile, FDA approval of Moderna's mRNA flu vaccine strengthens the case for applying mRNA technology to malaria and other diseases.
Scientists report progress in malaria vaccine development with new antibody-targeting approaches, while separate research reveals increasingly sophisticated drug resistance in malaria parasites. Meanwhile, FDA approval of Moderna's mRNA flu vaccine strengthens the case for applying mRNA technology to malaria and other diseases.
The Food and Drug Administration approved Moderna's mFlusiva on Wednesday, marking the first mRNA-based influenza vaccine authorized in the U.S. The vaccine is approved for adults aged 50 and older, representing a significant expansion of mRNA technology beyond COVID-19 vaccines.
The U.S. Food and Drug Administration has approved LYTENAVA (bevacizumab-vikg) for treating neovascular age-related macular degeneration (wet AMD), marking the first FDA-approved ophthalmic formulation of bevacizumab after 20 years of off-label use. The approval comes on Outlook Therapeutics' fourth regulatory attempt, though the company faces cash constraints as it enters commercialization.
The U.S. Food and Drug Administration approved a nonprescription fixed-dose combination pill containing acetaminophen (650 mg) and naproxen sodium (220 mg), marketed as Tylenol with Naproxen by Kenvue. The medication provides up to 12 hours of pain relief for patients aged 12 and older.
The FDA has approved Sanofi's Sarclisa (isatuximab) for subcutaneous delivery via a wearable on-body injector, marking the first cancer drug to receive approval for this delivery method. The device offers multiple myeloma patients a less burdensome alternative to intravenous infusions.
The U.S. Food and Drug Administration has granted accelerated approval to Vera Therapeutics' drug TRUTAKNA for treating adult patients with primary IgA nephropathy, a potentially life-threatening chronic autoimmune kidney disease. The approval sent Vera's shares up 6.8% in afternoon trading.
The FDA has approved Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel) for patients aged two years and older with sickle cell disease and transfusion-dependent beta thalassemia, expanding from the previous minimum age of 12 years. The approval was granted under the agency's Commissioner's National Priority Voucher program.
The U.S. FDA has approved Orca Bio's TREGZI, the first precision-engineered cell therapy for allogeneic transplants in adults with hematological malignancies, designed to reduce stem cell transplant complications.
The U.S. Food and Drug Administration has approved Viridian Therapeutics' Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease, marking the first FDA-approved treatment for the condition and setting up direct competition with Amgen's blockbuster drug Tepezza.
The FDA approved sacituzumab govitecan-hziy (Trodelvy) on June 24, 2026, for two indications in adults with triple-negative breast cancer: as monotherapy and in combination with pembrolizumab (Keytruda) for first-line treatment of advanced disease, offering new options beyond standard chemotherapy.
The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy, based on data from the phase 3 LITESPARK-022 trial.
The U.S. Food and Drug Administration on Tuesday approved bemotrizinol as a permitted active ingredient for over-the-counter sunscreens, marking the first new UV filter cleared since the late 1990s. The broad-spectrum ingredient has been widely used in Europe and Asia for years.
Cytokinetics announced its heart disease drug Myqorzo, already approved in one indication, succeeded in meeting twin efficacy goals in a Phase 3 trial for genetic heart disease, potentially boosting future sales.
