FDA Clears Masimo Medical Watch for OTC and Prescription Use
Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation and pulse rate for over-the-counter and prescription use, according to Masimo.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
FDA Approves Moderna’s Updated COVID-19 Vaccine
The 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.
FDA Approvals
Latest
FDA Approves Second OTC Naloxone Nasal Spray
The US Food and Drug Administration approved a 3-milligram naloxone hydrochloride nasal spray for over-the-counter, nonprescription use for the emergency treatment of known or suspected opioid overdose.
Innoviva’s Bacterial Pneumonia Treatment Secures FDA Approval
Xacduro was approved for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
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FDA Approves Oral Antiviral Pill for High-Risk COVID-19 Patients
Pfizer’s Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
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FDA Greenlights Prescription Nasal Spray to Reverse Opioid Overdose
The nalmefene hydrochloride nasal spray is indicated for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
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FDA Approves First RSV Vaccine
In clinical trials, the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1% in adults age 60 and older.
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Maxtec Launches FDA-cleared Oxygen and Pressure Monitor in US
Maxtec’s MaxO2 ME+p oxygen monitor with integrated pressure monitoring has received FDA clearance and is now available for purchase in the United States, according to Perma Pure Group.
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FDA Approves 20-valent Pneumococcal Vaccine for Infants and Children
The vaccine builds on the company’s previously approved vaccine by including seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases.
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FDA Approves Narcan Nasal Spray for OTC Use
The FDA approved Narcan 4 mg naloxone hydrochloride nasal spray for over-the-counter, nonprescription use. The approval is the first for a naloxone product without a prescription.
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FDA Issues EUA for Mpox Test
Authorized to be used in professional point-of-care settings, the nucleic acid amplification test can detect mpox virus and deliver results in 25 minutes.
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Bivalent Pfizer Booster Authorized for Infants and Young Children
The FDA expanded emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose for children 6 months through 4 years of age.
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FDA Green-lights Merck’s MMRV Vaccines for Intramuscular Injection
With these approvals, healthcare professionals now have the option to administer Merck’s measles, mumps, rubella, and varicella vaccines intramuscularly.
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FDA Okays Lucira COVID-19 & Flu Test, First OTC Home Combo Test
The US FDA issued an emergency use authorization for the Lucira COVID-19 & Flu Test, the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B and SARS-CoV-2.
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FDA Green-lights BD’s Combo RSV, Flu, COVID Test
BD received FDA emergency use authorization for its new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and respiratory syncytial virus (RSV).
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