Respiratory Therapy

7 Pharma Companies Chosen for FDA PreCheck Pilot Program

Jul 7, 2026 | FDA Approvals, US Pharmaceuticals

The FDA’s PreCheck Pilot Program will expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen US drug supply chain resilience.

HHS Ends COVID-19 Emergency Use Authorizations

Jul 3, 2026 | FDA Approvals, General Healthcare, Recalls & Advisories, Therapy Devices, US Pharmaceuticals

HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.

FDA Expands Casgevy for Children 2+ with Sickle Cell Disease

Jul 1, 2026 | FDA Approvals, Other Chronic Diseases, US Pharmaceuticals

The FDA approved the first gene therapy for children as young as 2 years old with sickle cell disease or transfusion-dependent beta thalassemia.

FDA Campaign Prevents 444,000 Youth From Starting E-cigarette Use

Jun 30, 2026 | Vaping & E-Cigarettes

New research shows “The Real Cost” educational efforts blocked millions in illegal e-cigarette sales and shifted youth attitudes toward nicotine addiction.

National Youth Tobacco Survey Reveals Youth Tobacco Use Reaches Historic Lows

Jun 30, 2026 | Nicotine Alternatives, Tobacco, Vaping & E-Cigarettes

Data from 2022 to 2025 indicate that current tobacco use, including e-cigarettes and cigarettes, has decreased among US middle and high school students.

FDA Authorizes Flavored Zyn Nicotine Pouches Despite Youth Risks

Jun 30, 2026 | FDA Approvals, Nicotine Alternatives

The FDA authorized 20 Zyn nicotine pouches, including 10 flavored products, despite concerns from health experts over increased youth use.

FDA Clears PanopticAI Respiratory Rate Monitoring

Jun 24, 2026 | FDA Approvals, Patient Monitoring

The software-as-a-medical-device allows for contactless measurement of respiratory and pulse rates using only a standard smartphone camera.

FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17

Jun 19, 2026 | FDA Approvals, Other Infections, US Pharmaceuticals

The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.

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.

Tag: FDA news

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7 Pharma Companies Chosen for FDA PreCheck Pilot Program

HHS Ends COVID-19 Emergency Use Authorizations

FDA Expands Casgevy for Children 2+ with Sickle Cell Disease

FDA Campaign Prevents 444,000 Youth From Starting E-cigarette Use

National Youth Tobacco Survey Reveals Youth Tobacco Use Reaches Historic Lows

FDA Authorizes Flavored Zyn Nicotine Pouches Despite Youth Risks

FDA Clears PanopticAI Respiratory Rate Monitoring

FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17

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7 Pharma Companies Chosen for FDA PreCheck Pilot Program

HHS Ends COVID-19 Emergency Use Authorizations

FDA Expands Casgevy for Children 2+ with Sickle Cell Disease

FDA Campaign Prevents 444,000 Youth From Starting E-cigarette Use

National Youth Tobacco Survey Reveals Youth Tobacco Use Reaches Historic Lows

FDA Authorizes Flavored Zyn Nicotine Pouches Despite Youth Risks

FDA Clears PanopticAI Respiratory Rate Monitoring

FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17

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

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