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.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
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.
FDA Approvals
Latest
FDA Expands Authorized Use of Regen-Cov as Preventative Treatment
The FDA expanded authorization of Regen-Cov to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
FDA Approves First Targeted Therapy for Specific Lung Cancer Mutation
The FDA approved sotorasib (Lumakras, Amgen Inc) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C.
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FDA Seeks $6.5B for 2022 Budget
The US FDA has requested a total budget of $6.5 billion as part of the President’s FY22 budget — a nearly 8% increase over FY21.
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FDA Approves Rybrevant for Certain NSC Lung Cancer Patients
The FDA has approved Janssen Pharma’s Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
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Pfizer Vaccine Authorized for Adolescents Ages 12-15
The FDA has expanded its emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine to children ages 12 to 15 years old. The vaccine had been authorized for individuals ages 16 and older.
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Higher Dosage of Naloxone Approved for Opioid Overdose
The FDA approved an 8mg dose naloxone hydrochloride nasal spray to treat opioid overdose, an increase from the previous 2 mg and 4 mg approved products.
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FDA Clears Getinge Servo-u MR, Software Options for Ventilator Fleet
The US FDA has issued clearance for several new software options for Getinge’s Servo-u and Servo-n ventilators, along with clearance for the company’s new Servo-u MR ventilator for the MRI room.
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Xolair Prefilled Syringe Approved for self-administration
The US FDA has approved Genetech’s Xolair (omalizumab) prefilled syringe for self-injection for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria, and nasal polyps.
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FDA Clears Donisi Contact-free Monitoring System
The Donisi system applies a combination of proprietary optics, algorithms, and AI to remotely detect and analyze surface-level micro-vibrations caused by the heart and lungs.
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FDA Authorizes Symbiotica COVID-19 Self-Collected Antibody Test
The US FDA has issued an EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
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FDA Approves First Device to Treat Congenital Heart Disease
The US FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System, the first in the world nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract.
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FDA Clears Belluscura’s Portable Oxygen Concentrator, X-plo2r
The US FDA has issued 510(k) clearance and marketing authorization to the X-plo2r portable oxygen concentrator from Belluscura PLC and Separation Design Group.
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First SARS-CoV-2 Test Granted Marketing Authorization
The FDA granted marketing authorization to the BioFire Respiratory Panel 2.1, the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the COVID-19 public health emergency.
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