FDA Approves OTC 12-Hour Cold and Fever Medication
The FDA approved over-the-counter Mucinex 12hr Cold & Fever Multi-Symptom.
Category: US Pharmaceuticals
US Pharmaceuticals
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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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HHS Ends COVID-19 Emergency Use Authorizations
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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FDA Expands Casgevy for Children 2+ with Sickle Cell Disease
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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Positive Data for Inhaled Pulmonary Arterial Hypertension Treatment
Once-daily treprostinil palmitil inhalation powder improved exercise capacity and reduced mortality risk for pulmonary arterial hypertension.
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Same-Day COVID-19 and Flu Vaccines Are Safe for Adults
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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Positive Ph3 Data for Aspergillosis Antifungal Treatment
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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CFTR Modulator Use Linked to Lower Anxiety in Children and Parents
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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