FDA Approves Amneal’s OTC Naloxone Nasal Spray
The nasal spray, available at pharmacies without a prescription, is designed to counteract opioid overdoses.
The nasal spray, available at pharmacies without a prescription, is designed to counteract opioid overdoses.
Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of Duchenne Muscular Dystrophy.
In some of the most notable pharmaceutical approvals from 2023, drugs for RSV, CF, COVID-19, sickle cell disease, and opioid overdose received an FDA stamp in 2023.
Augtyro was approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Read MoreThe US Food and Drug Administration cleared for marketing the first over-the-counter antigen test for COVID-19.
Read MoreThe US Food and Drug Administration has granted De Novo clearance to an over-the-counter, foot-worn medical pulse oximetry solution for infants.
Read MoreThe FDA granted Empatica 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.
Read MoreThe device is designed to improve insomnia by delivering a small electrical pulse to the head for 30 minutes before bed.
Read MoreThe FDA granted 510(k) clearance to the Bonhawa high-flow oxygen therapy system, designed to enhance the treatment of patients with respiratory insufficiency.
Read MoreThe FDA approved the combination therapy—previously approved for certain metastatic melanoma patients—for the treatment of metastatic non-small cell lung cancer with a BRAF V600E mutation.
Read MoreThe mRNA vaccines are formulated to more closely target currently circulating variants by including a monovalent component that corresponds to the Omicron variant XBB.1.5.
Read MoreThe FDA approved Moderna’s updated COVID-19 vaccine (Spikevax) for ages 12 years and above, and issued emergency use authorization for children age 6 months through 11 years old.
Read MoreThe US Food and Drug Administration has granted BodiMetrics 510k clearance for its circul pro ring as a pulse oximeter.
Read MoreThe US FDA has granted 510(k) clearance to the alveoair digital spirometer, according to a press release by the manufacturer, alveofit.
Read MoreLivaNova has received FDA 510(k) clearance for its Essenz In-Line Blood Monitor, which provides continuous measurement of blood parameters to perfusionists throughout cardiopulmonary bypass procedures.
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