Merck Wants to Extend RSV Vaccine to Second Season
FDA will review Enflonsia's ability to protect high-risk children under 2 years of age during their second RSV season.
Category: US Pharmaceuticals
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Merck Wants to Extend RSV Vaccine to Second Season
FDA will review Enflonsia’s ability to protect high-risk children under 2 years of age during their second RSV season.
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Application Accepted for Inhaled Pulmonary Fibrosis Treatment
If cleared by federal regulators, nebulized Tyvaso (treprostinil) Inhalation Solution would become the first inhaled option designed to treat idiopathic pulmonary fibrosis (IPF).
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FDA Approves Updated COVID-19 Vaccines for 2026-2027
Updated formulas from Pfizer, Moderna, and Novavax target the circulating XFG variant for older adults and high-risk populations.
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Asthma Antiviral Nasal Spray Secures Funding for Clinical Trial
A clinical trial will evaluate a weekly dry powder nasal spray’s ability to boost natural defenses and prevent asthma infections.
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CVS, Walgreens Now Offering Seasonal Flu Vaccines
CVS and Walgreens are expanding walk-in access, multi-vaccine scheduling, and respiratory illness testing ahead of peak viral activity.
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Study to Evaluate Effectiveness of Brensocatib for Bronchiectasis
The BEST-BE observational study will track 1,000 bronchiectasis patients to measure the impact of brensocatib on pulmonary exacerbations and patient quality of life.
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FDA Approves OTC 12-Hour Cold and Fever Medication
The FDA approved over-the-counter Mucinex 12hr Cold & Fever Multi-Symptom.
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FDA Approves First mRNA Flu Vaccine
The FDA approved Moderna’s mFlusiva, the first seasonal influenza vaccine using mRNA technology to enter the US market.
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FDA to Review RSV Drug Enflonsia for Children 2 and Younger
Merck is seeking expand approval for its RSV drug Enflonsia to include children under age two through their second year of risk.
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Azithromycin vs Roflumilast for AECOPD
A UCLA Health study compared azithromycin and roflumilast in protecting against acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
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FDA Approves Orzeyful for Narcolepsy Type 1
Orzeyful is the first drug to target the underlying loss of orexin signaling to address the full range of narcolepsy type 1.
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Remdesivir Tied to Better Long-Term Health for Kidney Transplant Recipients With COVID-19
In kidney transplant recipients, early antiviral treatment with remdesivir reduced the risk of organ rejection and heart complications by nearly half for up to one year after diagnosis.
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Duchenne Muscular Dystrophy Cell Therapy Preserves Heart, Muscle Function
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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Experimental Monoclonal Antibody Improved ARDS Outcomes
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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FDA Approves Zidesamtinib for Specific Type of Lung Cancer
Zidesamtinib (Jideytro) is approved for patients with ROS1-positive non-small cell lung cancer who have previously received targeted therapy.
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Breztri Aerosphere Now Available in the US for Asthma
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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Twice-yearly COPD Biologic Begins Trial
Windward Bio is evaluating WIN378, a monoclonal antibody designed for twice-yearly dosing in patients with moderate-to-severe COPD.
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Respiratory Biologics Have Significantly Reduced Asthma Exacerbations
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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FDA Accepts NDA for Apnimed Sleep Apnea Pill
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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Microneedle Patch for Peanut Allergies Begins Clinical Trials
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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Alpha-1 Antitrypsin Deficiency Drug Enters Ph3 Trial
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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RSV Antiviral Zelicapavir Enters Late-stage Clinical Trials
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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Ai-Generated Drug Rentosertib Trialed for Idiopathic Pulmonary Fibrosis
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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7 Pharma Companies Chosen for FDA PreCheck Pilot Program
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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