Respiratory Therapy

FDA Approves Generic Xofluza

Jun 17, 2026 | FDA Approvals, Influenza, US Pharmaceuticals

The FDA approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.

FDA Approves OTC Rextovy for Opioid Overdose

Jun 16, 2026 | Ambulance & EMS, FDA Approvals, US Pharmaceuticals

Rextovy, a 4 mg naloxone medication, will be available for purchase without a prescription at retail stores and online.

FDA: Urgent Correction for Baxter Volara System

Jun 11, 2026 | Recalls & Advisories, Therapy Devices

Baxter issued an Urgent Medical Device Correction notice for all Volara System patient circuits to be corrected prior to continued use, according to an FDA alert.

Early Alert for Hamilton Medical Ventilator Breathing Circuit

Jun 8, 2026 | Recalls & Advisories, Therapy Devices

Hamilton Medical issued updated use instructions for certain coaxial breathing circuit sets used with Hamilton-C1, Hamilton T-1, and Hamilton-MR1 ventilators, according to an FDA alert.

Early Alert for GE HealthCare Infant Resuscitation Systems

Jun 5, 2026 | Neonatal, Recalls & Advisories, Therapy Devices

GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use, according to an FDA alert.

VOCSN V+Pro Ventilators Recalled by React Health

May 21, 2026 | Recalls & Advisories, Therapy Devices

React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.

Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations

May 18, 2026 | ICU & Ventilation, Recalls & Advisories, Therapy Devices

A manufacturing error in the ventilator motor assembly may cause mechanical ventilation to fail before or during use, according to an FDA early alert.

FDA Approves Benralizumab for Hypereosinophilic Syndrome

May 15, 2026 | FDA Approvals, Other Chronic Diseases, US Pharmaceuticals

Benralizumab (Fasenra) is now indicated to reduce the risk of flare ups for adult and pediatric patients with hypereosinophilic syndrome.

CMS/FDA Launch New Pathway to Fast-Track Medicare Access for Medical Devices

Apr 29, 2026 | Home Care, Medicare & Medicaid, Recalls & Advisories

The RAPID coverage pathway aims to reduce delays between FDA authorization and Medicare coverage for breakthrough technologies.

FDA Launches Real-Time Clinical Trial Initiative

Apr 28, 2026 | Clinical Trials, Recalls & Advisories

The FDA is testing a new framework for monitoring safety signals as trials progress to reduce...

FDA Approves Breztri for Asthma Patients 12+

Apr 28, 2026 | FDA Approvals, US Pharmaceuticals

The single-inhaler therapy Breztri Aerosphere is now indicated for maintenance treatment in adults and pediatric patients who remain symptomatic on dual therapies.

Philips Issues New Ventilator Correction

Apr 16, 2026 | Recalls & Advisories, Therapy Devices

Philips has issued a recall for Trilogy ventilators be corrected prior to continued use, according to an FDA alert. The alert includes Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal devices.

FDA Approves IPF Generic Nintedanib

Apr 7, 2026 | FDA Approvals, Pulmonary Fibrosis, US Pharmaceuticals

Dexcel Pharma USA will launch nintedanib capsules for patients with progressive lung disease following final regulatory approval.

FDA Approves Age Limit Removal for Neffy Epinephrine Nasal Spray

Mar 27, 2026 | Allergies, FDA Approvals, Pediatric Care, US Pharmaceuticals

The updated label for the Neffy 1 mg dose allows children weighing at least 33 pounds to access the needle-free treatment regardless of age.

RSV Vaccine Arexvy Gets Expanded Approval for At-risk Adults 18-49

Mar 13, 2026 | FDA Approvals, RSV, US Pharmaceuticals

The expanded approval means Arexvy is now indicated for all adults aged 60 and older, and adults aged 18–59 at increased risk for LRTD caused by RSV.

FDA Replaces Adverse Event Reporting Systems

Mar 12, 2026 | Recalls & Advisories

The FDA launched its Adverse Event Monitoring System (AEMS), a new unified platform that allows reports for drugs, biologics, vaccines, cosmetics, and animal food to be displayed in a single streamlined dashboard.

FDA Advances Biosimilar Pharma Development

Mar 9, 2026 | FDA Approvals, US Pharmaceuticals

By reducing redundant pharmacokinetic testing requirements, the FDA estimates biosimilar developers could cut study costs by up to 50%.

FDA Approves First Flovent Generic for Asthma

Mar 4, 2026 | Asthma, FDA Approvals, US Pharmaceuticals

The generic Flovent HFA (fluticasone propionate) inhalation aerosol is approved as a maintenance therapy for asthma in patients aged 4 years and older.

FDA, European Commission Grant Orphan Drug Designation for New IPF Treatment

Mar 2, 2026 | Intl' Pharmaceuticals, US Pharmaceuticals

Deupirfenidone showed a slower rate of lung function decline compared to existing therapies in a...

FDA Launches PreCheck Pilot Program for Pharmaceuticals

Feb 2, 2026 | FDA Approvals, US Pharmaceuticals

The US FDA is accepting requests to participate in the FDA PreCheck pilot program, designed to streamline US-based manufacturing of pharmaceuticals.

FDA Guidance to Update Clinical Trials

Jan 12, 2026 | Clinical Trials, FDA Approvals

The FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics.

AAP Opposes HHS Changes to Childhood Immunization Schedule

Jan 5, 2026 | Association News, Other Infections, Pediatric Care

AAP president Andrew D. Racine is raising alarms over the federal government’s removal of several vaccinations from its Childhood Immunization Schedule.

FDA Approves Jascayd/Nerandomilast for Progressive Pulmonary Fibrosis

Dec 19, 2025 | FDA Approvals, Pulmonary Fibrosis, US Pharmaceuticals

The US FDA has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults, according to Boehringer Ingelheim.

FDA Eliminates Limitation on Real-World Evidence

Dec 16, 2025 | FDA Approvals, Recalls & Advisories

The US FDA removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.

Tag: FDA news

All

FDA Approves Generic Xofluza

FDA Approves OTC Rextovy for Opioid Overdose

FDA: Urgent Correction for Baxter Volara System

Early Alert for Hamilton Medical Ventilator Breathing Circuit

Early Alert for GE HealthCare Infant Resuscitation Systems

VOCSN V+Pro Ventilators Recalled by React Health

Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations

FDA Approves Benralizumab for Hypereosinophilic Syndrome

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FDA Approves Generic Xofluza

FDA Approves OTC Rextovy for Opioid Overdose

FDA: Urgent Correction for Baxter Volara System

Early Alert for Hamilton Medical Ventilator Breathing Circuit

Early Alert for GE HealthCare Infant Resuscitation Systems

VOCSN V+Pro Ventilators Recalled by React Health

Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations

FDA Approves Benralizumab for Hypereosinophilic Syndrome

CMS/FDA Launch New Pathway to Fast-Track Medicare Access for Medical Devices

FDA Launches Real-Time Clinical Trial Initiative

FDA Approves Breztri for Asthma Patients 12+

Philips Issues New Ventilator Correction

FDA Approves IPF Generic Nintedanib

FDA Approves Age Limit Removal for Neffy Epinephrine Nasal Spray

RSV Vaccine Arexvy Gets Expanded Approval for At-risk Adults 18-49

FDA Replaces Adverse Event Reporting Systems

FDA Advances Biosimilar Pharma Development

FDA Approves First Flovent Generic for Asthma

FDA, European Commission Grant Orphan Drug Designation for New IPF Treatment

FDA Launches PreCheck Pilot Program for Pharmaceuticals

FDA Guidance to Update Clinical Trials

AAP Opposes HHS Changes to Childhood Immunization Schedule

FDA Approves Jascayd/Nerandomilast for Progressive Pulmonary Fibrosis

FDA Eliminates Limitation on Real-World Evidence

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