FDA Authorizes Updated Novavax COVID-19 Vaccine Â
The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.Â
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
FDA Expands Approval of Palforzia for Peanut Allergy Treatment in Children
Palforzia is now approved for treating peanut allergies in children ages 1 to 3, expanding its use beyond the previous age range of 4 to 17.
FDA Approvals
Latest
FDA Approves Amphastar’s Generic Albuterol Sulfate
The FDA approved Amphastar’s abbreviated new drug application for its albuterol sulfate inhalation aerosol, a generic for Teva’s ProAir HFA.
FDA Approves New Antibiotic for Community-acquired Bacterial PneumoniaÂ
The injection received FDA approval for adults and pediatric patients aged 3 months and older.Â
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Respiratory Sore Throat Diagnostic Cleared by FDA
The BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance and CLIA) waiver approval, according to bioMérieux.
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Biofire Spotfire R/ST Panel Gets 510(k) Clearance, CLIA-waiver Approval
bioMérieux received FDA 510(k) clearance and CLIA waiver approval for the Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel.
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FDA Approves Merck’s Injection for Pulmonary Arterial Hypertension
The injection on top of background therapy significantly improved exercise capacity and multiple secondary outcome measures compared to background therapy alone.
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FDA Authorizes Pemgarda for COVID-19 Prevention
Invivyd’s Pemgarda receives FDA authorization for COVID-19 prevention in immunocompromised individuals. Explore the significance of this breakthrough therapy and its potential to safeguard vulnerable populations against the virus.
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FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of Duchenne Muscular Dystrophy.
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FDA Approves Osimertinib plus Chemotherapy for EGFR-mutated NSCLC
The FDA approved osimertinib (Tagrisso) with platinum-based chemotherapy for certain patients with non-small cell lung cancer (NSCLC).
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FDA Approves Xolair as First Drug to Treat Food Allergies
Previously approved to treat asthma and nasal polyps, Xolair has now received FDA approval as the first treatment for reducing food allergy reactions in both children and adults.
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FDA Clears First Over-the-Counter Pulse Oximeter
The clearance makes it the first FDA-cleared medical fingertip pulse oximeter available OTC direct to consumers without a prescription.
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FDA Clears NuvoAir’s Air Next Spirometer for Home Use
The clearance allows Air Next to conduct full spirometry at home, providing clinical data that ensures patients can be monitored continuously.
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FDA Clears AI Software for Lung Segment Analysis in CT Scans
The technology performs an analysis of the lung tissue and the fissure completeness, supporting physicians in the diagnosis and documentation of pulmonary tissue images from CT thoracic datasets for each patient.
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FDA Clears INOmax Evolve DS
The INOmax Evolve DS is Mallinckrodt’s next-generation nitric oxide delivery system that includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.
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