Youth E-Cigarette Use Falls to One-Third of 2019 Peak
New data from the FDA and CDC reveals that e-cigarette use among US youth has dropped to 1.63 million in 2024, down from over 5 million in 2019.
Tag: FDA news
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FDA Grants Orphan Drug Status to Lung Cancer Antibody-Drug Conjugate
The investigational therapy, targeting the B7-H3 antigen, has shown promising tumor-killing effects and a good safety profile in preclinical models.
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FDA Clears bioMérieux Vitek Reveal AST System
bioMérieux received US FDA 510(k) clearance for its Vitek Reveal AST System, which reports results directly from positive blood cultures.
FDA Reopens Review of Juul Vaping Products After Rescinding Ban
The FDA has canceled its previous orders denying Juul the ability to market its e-cigarette products in the US, allowing the vaping giant to re-enter the regulatory review process.
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FDA Grants Orphan Drug Designation to Inhaled Treatment for IPF
AGMB-447, a small-molecule inhibitor of ALK5, is being evaluated in a phase 1 clinical trial.
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FDA Fast Tracks Investigational Cystic Fibrosis Drug
SPL84, an antisense oligonucleotide treatment for cystic fibrosis patients with a specific mutation, gains FDA Fast Track designation.
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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.
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FDA Recognizes Lung Infection Test for Immunocompromised Patients
The test was granted FDA Breakthrough Device status for its potential to improve the diagnosis of lung infections in immunocompromised patients.
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Philips Recalls Trilogy Evo Ventilators Due to Risk of Power Malfunction
Philips Respironics Inc is recalling its Trilogy Evo continuous ventilators due to a possible software-related power malfunction.
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FDA: New Guidance on ‘Remanufacturing’ for Reusable Medical Devices, Including Ventilators
The FDA has issued final guidance to clarify the definition of “remanufacturing” for reusable medical devices needing maintenance or repair.
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FDA Clears GE Healthcare’s Portable Vital Signs Monitor
Portrait VSM provides readings for blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate.
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SonarMed Recalls Airway Sensors Due Failure to Detect Partial ObstructionsÂ
The recall of the sensors, used in conjunction with the SonarMed airway monitoring system, is due to a restricted inner diameter that impedes the passage of suction catheters.
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1 in 5 Grocery Store Milk Samples Test Positive for Bird Flu
The FDA found traces of bird flu in milk samples sourced from grocery store shelves. Why the agency says the milk is still safe to drink.
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FDA Approves Amneal’s OTC Naloxone Nasal Spray
The nasal spray, available at pharmacies without a prescription, is designed to counteract opioid overdoses.
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Federal Court Finalizes Consent Decree Against Philips RespironicsÂ
The decree mandates a recall remediation plan and production restrictions to address safety concerns following the widespread 2021 recall of CPAP and BiPAP machines.
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