FDA Approves Updated COVID Vaccines from Pfizer and Moderna
The 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.
Category: FDA Approvals
FDA Approvals
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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.
FDA Approvals
Latest
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.
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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FDA Approves 2nd Gen Genosyl Delivery System for Anesthesia
Vero Biotech expects the new indication for its device for rebreathing anesthesia to provide significant benefits to the anesthesiology and surgical care communities.
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ACCP Recommends Removal of OTC Epinephrine for Asthma
The association joins other medical organizations in emphasizing the hazards of over-the-counter availability of inhaled epinephrine products for the treatment of asthma.
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FDA Approves Sublingual Drug for Dust Mite Allergy for Adolescents
The FDA expanded its approval of Odactra, a sublingual allergen extract to treat house dust mite-induced allergic rhinitis, to ages 12 through 17.
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3rd Generation Tankless Inhaled Nitric Oxide System Gets FDA Approval
The US FDA has approved the third Generation Genosyl Delivery System, a tankless inhaled nitric oxide (iNO) therapy device, according to manufacturer Vero Biotech Inc.
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FDA Approves Airsupra Asthma Rescue Inhaler
AstraZeneca’s Airsupra is the first FDA-approved combination of an inhaled corticosteroid and a short-acting beta-agonist for prevention of asthma exacerbations.
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FDA Expands Clearance of Luna G3 Bilevel for NIV
The Luna G3 Bilevel S/T 30Vt was granted 510(k) clearance by the US FDA for use as a noninvasive ventilator (NIV), according to manufacturer React Health.
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FDA, CDC Authorize Bivalent COVID Vaccines for Children as Young as 6 Months Old
The US FDA recently updated its emergency use authorizations for bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. The CDC signed off on the authorizations the following day.
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FDA Clears EXSALTA Secretion Clearance Device
DRW Medical’s EXSALTA is the first peristaltic suction device for clearing endotracheal tube secretions for patients on ventilators.
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FDA Authorizes Moderna, Pfizer Bivalent Boosters for Children 5 and Older
The FDA has authorized bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech as a single booster dose in younger age groups, according to the agency.
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