Results from the HOPE-3 trial found that an investigational cell therapy called deramiocel preserved heart and muscle function in boys and young men with Duchenne muscular dystrophy (DMD).
Results from the HOPE-3 trial found that an investigational cell therapy called deramiocel preserved heart and muscle function in boys and young men with Duchenne muscular dystrophy (DMD).
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A proof-of-concept study showed an experimental monoclonal antibody targeting ARDS inflammation increased ventilator-free days and reduced organ failure.
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Zidesamtinib (Jideytro) is approved for patients with ROS1-positive non-small cell lung cancer who have previously received targeted therapy.
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AstraZeneca’s triple-combination asthma therapy Breztri Aerosphere was approved in April 2026 for adults and pediatric patients age 12 and older.
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Windward Bio is evaluating WIN378, a monoclonal antibody designed for twice-yearly dosing in patients with moderate-to-severe COPD.
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A large-scale study finds that the introduction of asthma biologics in 2015 has led to immediate and sustained reductions in exacerbations at the population level.
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The FDA will review a New Drug Application for Apnimed’s AD109, an investigational oral pill for the treatment of adults with obstructive sleep apnea with a target action date of Feb 28, 2027.
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A phase 1 study is testing the safety of a microneedle device designed to deliver peanut protein through the skin for desensitization.
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Grifols enrolled the first patient in its Phase 3 SWIFT-SC clinical trial to evaluate its subcutaneous Alpha1-Proteinase Inhibitor for the treatment of alpha1-antitrypsin (AAT) deficiency.
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Enanta Pharma advanced zelicapavir into a registrational Phase 2b/3 clinical trial for adults at high risk of severe RSV outcomes.
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Insilico Medicine initiated a Phase 3 clinical trial for Rentosertib, an oral medication discovered using artificial intelligence to treat idiopathic pulmonary fibrosis (IPF).
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The FDA’s PreCheck Pilot Program will expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen US drug supply chain resilience.
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HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.
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The FDA approved the first gene therapy for children as young as 2 years old with sickle cell disease or transfusion-dependent beta thalassemia.
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Once-daily treprostinil palmitil inhalation powder improved exercise capacity and reduced mortality risk for pulmonary arterial hypertension.
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Research involving 2.5 million patients found no increase in serious adverse events when receiving both COVID-19 and influenza vaccinations during the same visit.
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Phase 3 trial results indicate a new antifungal medication olorofim is as effective as current standard treatments for invasive aspergillosis with fewer side effects.
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New research suggests cystic fibrosis transmembrane conductance regulator (CFTR) modulators may provide mental health benefits for pediatric patients and their caregivers early in treatment.
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The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.
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The FDA approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.
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Rextovy, a 4 mg naloxone medication, will be available for purchase without a prescription at retail stores and online.
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ENA Respiratory received notices of allowance for two US patents covering its innate immune modulators and their application in preventing COPD exacerbations.
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Researchers discovered manikomycin, a soil-derived peptide that attacks bacteria in a unique way to bypass existing antibiotic resistance.
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Real-world data published in JAMA Network Open confirm the effectiveness of the RSVpreF vaccine in protecting newborns from respiratory syncytial virus.
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