FDA Approvals Archives

FDA Approves Biosimilar Omlyclo for Asthma

Mar 10, 2025 | Allergies, Asthma, FDA Approvals, Other Chronic Diseases, US Pharmaceuticals

Omlyclo (omalizumab-igec) is the first and only biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate to severe persistent asthma, CRSwNP, IgE-mediated food allergy, and chronic spontaneous urticaria.

FDA Clears Visby Medical Flu + COVID Test

Feb 26, 2025 | Coronavirus, FDA Approvals, Influenza, Testing

Visby Medical’s handheld PCR test that differentiates between influenza A, B, and COVID-19 received FDA clearance and a CLIA waiver.

FDA Approves New Class of Non-Opioid Pain Medication

Feb 7, 2025 | FDA Approvals, US Pharmaceuticals

The FDA has approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults, according to the agency.

FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease

Jan 13, 2025 | FDA Approvals

The AI-powered tool automatically assesses medical data for interstitial lung findings compatible with interstitial lung disease.

FDA Clears Simeox 200 Airway Clearance Device

Jan 2, 2025 | FDA Approvals, Therapy Devices

The device is intended to promote and improve bronchial drainage by using high-frequency oscillatory vibrations and intermittent negative pressure.

FDA Approves Zenocutuzumab-zbco for NSCLC and Pancreatic Adenocarcinoma

Dec 9, 2024 | FDA Approvals, Lung Cancer, US Pharmaceuticals

The FDA says the approval marks the first systemic therapy for non–small cell lung cancer and pancreatic adenocarcinoma harboring NRG1 gene fusions.

FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer

Dec 5, 2024 | FDA Approvals

AstraZeneca’s Imfinzi (durvalumab) has been approved in the United States for the treatment of adult patients with limited-stage small cell lung cancer.

FDA Clears Pulse Oximeter in EvieMED Ring

Dec 3, 2024 | FDA Approvals, Patient Monitoring

Movano Health has secured US Food and Drug Administration clearance for the pulse oximeter in the EvieMED Ring.

FDA Clears Nonin OTC Pulse Oximeter Designed for Accuracy Across Skin Tones

Dec 2, 2024 | FDA Approvals, Patient Monitoring

The FDA has granted 510(k) clearance for an over-the-counter fingertip pulse oximeter designed to provide accurate blood oxygen readings across all skin tones.

FDA Clears Single-Use Chest-Based Wearable for Patient Monitoring

Nov 25, 2024 | FDA Approvals, Patient Monitoring

The cloud-based monitoring solution uses a single-use biosensor to track vital signs like SpO2, ECG, and body temperature across home, remote, and hospital settings.

FDA Clears CorVent’s Respond Ventilator

Nov 20, 2024 | FDA Approvals, Therapy Devices

CorVent Medical’s Respond ventilator, offering both invasive and non-invasive capabilities, has received FDA 510(k) clearance.

FDA Approves Dupixent for COPD

Sep 27, 2024 | COPD, FDA Approvals, US Pharmaceuticals

The FDA has approved Dupixent for adults with inadequately controlled COPD and an eosinophilic phenotype.

Osimertinib Approved for Certain Stage III NSCLC Patients Following Chemoradiation

Sep 26, 2024 | FDA Approvals

The FDA has approved osimertinib for adult patients with stage III NSCLC whose tumors have specific EGFR mutations, following chemoradiation therapy.

FDA Approves First Influenza Vaccine for Self-Administration

Sep 20, 2024 | FDA Approvals, Pediatric Care, US Pharmaceuticals

The nasal spray flu vaccine is available for self- or caregiver-administration by prescription for individuals aged 2 to 49.

FDA Clears Oral Appliance to Treat Moderate to Severe Sleep Apnea in Children

Sep 18, 2024 | FDA Approvals, Pediatric Care, Sleep Apnea, Therapy Devices

The oral appliance is now approved to treat moderate to severe OSA and reduce snoring in children aged 6 to 17.

FDA Approves Dupixent for Chronic Rhinosinusitis with Nasal Polyps in Adolescents

Sep 16, 2024 | FDA Approvals, Other Chronic Diseases, US Pharmaceuticals

The FDA has approved Dupixent as an add-on maintenance treatment for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps, expanding its original approval for adults in 2019.

Under-Mattress Mat Gets FDA Clearance for Home Sleep Apnea Screening

Sep 9, 2024 | Diagnostics, FDA Approvals, Sleep Apnea

The US FDA has granted 510(k) clearance to a contactless, under-the-mattress device designed to aid in the diagnosis of obstructive sleep apnea.

FDA Authorizes Updated Novavax COVID-19 Vaccine

Aug 30, 2024 | FDA Approvals

The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.

FDA Clears Ear-Worn Pulse Oximeter

Aug 28, 2024 | FDA Approvals

The wearable provides continuous, real-time measurement of blood oxygen saturation and pulse rate.

FDA OKs Updated Moderna and Pfizer-BioNTech COVID-19 Vaccines

Aug 22, 2024 | FDA Approvals

The FDA has approved and authorized updated Moderna and Pfizer-BioNTech COVID-19 vaccines for the 2024-2025 season, designed to target current variants.

FDA Clears SoClean 3+ CPAP Bacterial Reduction Device

Aug 20, 2024 | FDA Approvals, Sleep Apnea

The device is intended to be used as an adjunct to reduce bacteria on certain CPAP masks and hoses after cleaning.

FDA Approves Durvalumab-Chemo Combo for Resectable NSCLC

Aug 16, 2024 | FDA Approvals, Lung Cancer, US Pharmaceuticals

The approval was based on trial results which showed the regimen reduced the risk of recurrence, progression, or death by 32% versus neoadjuvant chemotherapy alone.

FDA Clears Masimo W1 Watch for Connectivity with Telemonitoring System

Aug 12, 2024 | FDA Approvals, Patient Monitoring

The Masimo W1 medical watch, now FDA-cleared for integration with Masimo SafetyNet, enables continuous remote monitoring of vital signs.

FDA Approves First Epinephrine Nasal Spray for Anaphylaxis

Aug 9, 2024 | FDA Approvals

The epinephrine nasal spray provides a needle-free option for rapid emergency treatment of severe allergic reactions.

Category: FDA Approvals

FDA Approvals

FDA Approves Biosimilar Omlyclo for Asthma

FDA Clears Visby Medical Flu + COVID Test

FDA Approves New Class of Non-Opioid Pain Medication

FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease

FDA Clears Simeox 200 Airway Clearance Device

FDA Approves Zenocutuzumab-zbco for NSCLC and Pancreatic Adenocarcinoma

FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer

FDA Clears Pulse Oximeter in EvieMED Ring

Subscribe To Our Newsletter

You have Successfully Subscribed!

FDA Approves Biosimilar Omlyclo for Asthma

FDA Clears Visby Medical Flu + COVID Test

FDA Approves New Class of Non-Opioid Pain Medication

FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease

FDA Clears Simeox 200 Airway Clearance Device

FDA Approves Zenocutuzumab-zbco for NSCLC and Pancreatic Adenocarcinoma

FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer

FDA Clears Pulse Oximeter in EvieMED Ring

FDA Clears Nonin OTC Pulse Oximeter Designed for Accuracy Across Skin Tones

FDA Clears Single-Use Chest-Based Wearable for Patient Monitoring

FDA Clears CorVent’s Respond Ventilator

FDA Approves Dupixent for COPD

Osimertinib Approved for Certain Stage III NSCLC Patients Following Chemoradiation

FDA Approves First Influenza Vaccine for Self-Administration

FDA Clears Oral Appliance to Treat Moderate to Severe Sleep Apnea in Children

FDA Approves Dupixent for Chronic Rhinosinusitis with Nasal Polyps in Adolescents

Under-Mattress Mat Gets FDA Clearance for Home Sleep Apnea Screening

FDA Authorizes Updated Novavax COVID-19 Vaccine

FDA Clears Ear-Worn Pulse Oximeter

FDA OKs Updated Moderna and Pfizer-BioNTech COVID-19 Vaccines

FDA Clears SoClean 3+ CPAP Bacterial Reduction Device

FDA Approves Durvalumab-Chemo Combo for Resectable NSCLC

FDA Clears Masimo W1 Watch for Connectivity with Telemonitoring System

FDA Approves First Epinephrine Nasal Spray for Anaphylaxis

Respiratory Therapy

Our Parent Company

Key Resources

Helpful Links