New ‘Breakthrough’ Therapy for Non-CF Bronchiectasis
The US FDA recently granted Breakthrough Therapy Designation to a novel inhaled therapy called CMS I-neb, which is designed to treat non-CF bronchiectasis.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
First COVID-19 Breathalyzer Test Authorized by FDA
The FDA authorized the InspectIR COVID-19 Breathalyzer -- the first COVID test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
FDA Approvals
Latest
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.
Pfizer Paxlovid COVID Antiviral Pill Authorized by FDA
The US FDA has authorized the emergency use of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients age 12 and older.
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FDA Expands Authorization of Pfizer Booster to 16-17 Year Olds
The FDA expanded emergency use for the Pfizer-BioNTech COVID-19 Vaccine single booster dose to teens 16 and 17 years of age.
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FDA Advisory Committee Supports Pfizer Vaccine for Kids Age 5-11
An FDA vaccine advisory committee voted 17 to 0 to recommend the emergency use of the Pfizer/BioNTech COVID-19 vaccine in children 5 to <12 years of age.
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FDA Authorizes Moderna and Janssen Boosters
The FDA authorized single booster doses for the Moderna Inc and Janssen COVID-19 vaccines for certain adults age 18 and older, as well as the use of “mix and match” boosters of differing vaccines.
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Dupilumab Gets Expanded Approval for Moderate-to-severe Asthma in Children Age 6-11
The FDA has approved dupilumab (Dupixent, Regeneron) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
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FDA Authorizes OTC Flowflex COVID-19 Home Test
The FDA has issued an emergency use authorization for the Acon Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test.
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FDA Advisory Committee Unanimously Supports Moderna Booster Dose for Seniors, at-risk Adults
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend emergency use authorization for a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level.
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FDA Approves Tecentriq for Early NSC Lung Cancer
The FDA has approved atezolizumab (brand name Tecentriq, Genetech) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer.
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FDA Authorizes First Vaping Products as Potential Smoking Cessation Aids
The FDA has authorized the marketing of three Vuse vaping devices — the first electronic nicotine delivery system (ENDS) products to be authorized by the agency.
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FDA Clears PulmoScan at-home PFT Device
The US FDA has issued clearance for Cognita Labs’ PulmoScan, the first at-home lung assessment device that measures airway resistance and elastance.
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FDA Clears Siemens Healthineers’ First-of-its-kind CT Scanning Device
The US FDA has cleared the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner.
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BreathSuite Metered-dose Inhaler Cleared by FDA
The BreatheSuite V1 turns existing metered-dose inhalers into smart inhalers by automatically and objectively monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD.
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