FDA Licenses First Freeze-dried Emergency Plasma
The room-temperature-stable freeze-dried plasma product provides a new option for patients in remote or austere environments where conventional frozen plasma is unavailable.
Tag: FDA news
All
Latest
FDA Licenses First Freeze-dried Emergency Plasma
The room-temperature-stable freeze-dried plasma product provides a new option for patients in remote or austere environments where conventional frozen plasma is unavailable.
Read More
Early Alert for Baxter Duo-Vent Solution Sets
Baxter has recommended removal of certain Duo-Vent solution sets used for administration of fluids to the patient’s vascular system.
Read More
FDA Issues Early Alert for Resmed Ventilators
Resmed has recommended corrections to certain Astral 100 and Astral 150 ventilators due to an issue that may result in interrupted therapy.
Read More
FDA Accepts NDA for Apnimed Sleep Apnea Pill
The FDA will review a New Drug Application for Apnimed’s AD109, an investigational oral pill for the treatment of adults with obstructive sleep apnea with a target action date of Feb 28, 2027.
Read More
FDA Authorizes Syncron-E Software for Patient-Ventilator Asynchrony
Autonomous Healthcare received FDA De Novo marketing authorization for Syncron-E, a software that supports the assessment of patient-ventilator asynchrony by detecting evidence of ineffective efforts.
Read More
7 Pharma Companies Chosen for FDA PreCheck Pilot Program
The FDA’s PreCheck Pilot Program will expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen US drug supply chain resilience.
Read More
HHS Ends COVID-19 Emergency Use Authorizations
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.
Read More
FDA Expands Casgevy for Children 2+ with Sickle Cell Disease
The FDA approved the first gene therapy for children as young as 2 years old with sickle cell disease or transfusion-dependent beta thalassemia.
Read More
Saline Nasal Spray Recalled Due to Contamination Risk
Beekeeper’s Naturals issued a voluntary nationwide recall for one lot of its saline nasal spray because of potential microbial contamination, according to an alert from the USFDA.
Read More
FDA Clears AMDI Fast PCR Respiratory Panel for Point-of-Care Testing
The AMDI Fast PCR System provides point-of-care results for RSV, influenza, and COVID-19 in less than 10 minutes.
Read More
FDA Campaign Prevents 444,000 Youth From Starting E-cigarette Use
New research shows “The Real Cost” educational efforts blocked millions in illegal e-cigarette sales and shifted youth attitudes toward nicotine addiction.
Read More
National Youth Tobacco Survey Reveals Youth Tobacco Use Reaches Historic Lows
Data from 2022 to 2025 indicate that current tobacco use, including e-cigarettes and cigarettes, has decreased among US middle and high school students.
Read More
FDA Authorizes Flavored Zyn Nicotine Pouches Despite Youth Risks
The FDA authorized 20 Zyn nicotine pouches, including 10 flavored products, despite concerns from health experts over increased youth use.
Read More
FDA Clears PanopticAI Respiratory Rate Monitoring
The software-as-a-medical-device allows for contactless measurement of respiratory and pulse rates using only a standard smartphone camera.
Read More
FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17
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.
Read More
FDA Approves Generic Xofluza
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.
Read More
FDA Approves OTC Rextovy for Opioid Overdose
Rextovy, a 4 mg naloxone medication, will be available for purchase without a prescription at retail stores and online.
Read More
FDA: Urgent Correction for Baxter Volara System
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.
Read More
Early Alert for Hamilton Medical Ventilator Breathing Circuit
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.
Read More
Early Alert for GE HealthCare Infant Resuscitation Systems
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.
Read More
VOCSN V+Pro Ventilators Recalled by React Health
React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.
Read More
Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations
A manufacturing error in the ventilator motor assembly may cause mechanical ventilation to fail before or during use, according to an FDA early alert.
Read More
FDA Approves Benralizumab for Hypereosinophilic Syndrome
Benralizumab (Fasenra) is now indicated to reduce the risk of flare ups for adult and pediatric patients with hypereosinophilic syndrome.
Read More
CMS/FDA Launch New Pathway to Fast-Track Medicare Access for Medical Devices
The RAPID coverage pathway aims to reduce delays between FDA authorization and Medicare coverage for breakthrough technologies.
Read More