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.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
FDA Approves Comirnaty COVID Vaccine for 12-15 Year Olds
The FDA approved the Pfizer/BioNTech SARS-CoV-2 vaccine (Comirnaty) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age.
FDA Approvals
Latest
FDA Authorizes First COVID-Flu-RSV Test Without a Prescription
The US FDA authorized use of the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test -- the first COVID-Flu-RSV test without the need for a prescription.
New FDA Clearance for Philips Capsule Surveillance
The latest Philips Capsule Surveillance solution has received 510(k) market clearance from the US FDA, according to a company announcement at HIMSS 2022.
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FDA Approves First Symbicort Generic to Treat Asthma and COPD
The US FDA approved the first Symbicort generic inhalation aerosol from Mylan Pharmaceuticals for the treatment of asthma and COPD.
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FDA Approves Generic Roflumilast for COPD
The FDA has approved a generic version of roflumilast manufactured by Zydus Pharmaceuticals USA Inc for the treatment of COPD.
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FDA Delays Meeting on Pfizer Vaccine for Children 6-months to Age 5
The FDA has postponed a Feb 15 meeting of its Vaccines and Related Biological Products Advisory Committee that was intended to discuss emergency use authorization of a two-dose regimen of the Pfizer-BioNTech vaccine for children age 6-months through 4-years-old.
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FDA Authorizes New Omicron-effective Monoclonal Antibody Bebtelovimab
The FDA authorized Eli Lilly and Co’s bebtelovimab, a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant.
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Medtronic RespArray Patient Monitor Cleared by FDA
Medtronic plc received US FDA 510(k) clearance for its RespArray patient monitor, designed for procedural sedation and medical-surgical units.
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Pfizer Vaccine Submitted for Children 6-months through 4-Years-Old
Pfizer and BioNTech have submitted an application for emergency authorization of its COVID-19 vaccine in children age 6 months through 4 years old.
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FDA Approves Moderna COVID-19 Vaccine
The US FDA has approved the Moderna COVID-19 Vaccine (marketed as “Spikevax”) for the prevention of COVID-19 in individuals 18 years of age and older.
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FDA Clears Wesper Wireless Patch Home Sleep Test
The Wesper platform assists trained personnel in the diagnosis of sleep apnea with data from a wireless patch component the user can apply to their body in the comfort of their own bed.
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Pathogenomix Rapid Test Granted Breakthrough Device Status
Pathogenomix Inc’s Patho-Seq is designed for the rapid detection and identification of bacteria for a broad list of clinical conditions and sample types, including sepsis from whole blood samples and bacterial meningitis from CSF.
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FDA Clears GEM Hemochron 100 Whole Blood Hemostasis Testing System
Werfen has received FDA 510(k) clearance for its GEM Hemochron 100 whole blood hemostasis system, which will be commercialized in the US in early 2022.
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Inhaled Albuterol Sulfate Solutions FDA-approved
The FDA approved an abbreviated new drug application for Albuterol Sulfate Inhalation Solution for patients 2 to 12 years of age with asthma.
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