FDA Clears HoneyNaps Ai Software for Sleep Apnea Analysis
The USFDA granted 510(k) clearance for the HoneyNaps Somnum V3.0 Ai-based software for polysomnography (PSG) analysis, according to the company.
Category: FDA Approvals
FDA Approvals
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FDA Clears HoneyNaps Ai Software for Sleep Apnea Analysis
The USFDA granted 510(k) clearance for the HoneyNaps Somnum V3.0 Ai-based software for polysomnography (PSG) analysis, according to the company.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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FDA Approves More Vaping Products
The FDA authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application pathway.
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FDA Approves Breztri for Asthma Patients 12+
The single-inhaler therapy Breztri Aerosphere is now indicated for maintenance treatment in adults and pediatric patients who remain symptomatic on dual therapies.
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FDA Approves IPF Generic Nintedanib
Dexcel Pharma USA will launch nintedanib capsules for patients with progressive lung disease following final regulatory approval.
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FDA Approves Expanded Indications for CF Drugs Alyftrek, Trikafta
New label extensions for Alyftrek and Trikafta make approximately 95% of the cystic fibrosis population in the United States eligible for treatment.
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FDA Approves Age Limit Removal for Neffy Epinephrine Nasal Spray
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.
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RSV Vaccine Arexvy Gets Expanded Approval for At-risk Adults 18-49
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.
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FDA Advances Biosimilar Pharma Development
By reducing redundant pharmacokinetic testing requirements, the FDA estimates biosimilar developers could cut study costs by up to 50%.
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FDA Approves First Flovent Generic for Asthma
The generic Flovent HFA (fluticasone propionate) inhalation aerosol is approved as a maintenance therapy for asthma in patients aged 4 years and older.
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FDA Launches PreCheck Pilot Program for Pharmaceuticals
The US FDA is accepting requests to participate in the FDA PreCheck pilot program, designed to streamline US-based manufacturing of pharmaceuticals.
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FDA Guidance to Update Clinical Trials
The FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics.
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FDA Approves Ultra-long-acting Biologic Depemokimab for Severe Asthma
Depemokimab is a twice-yearly administered monoclonal antibody approved for patients with severe asthma with an eosinophilic phenotype.
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FDA Approves Jascayd/Nerandomilast for Progressive Pulmonary Fibrosis
The US FDA has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults, according to Boehringer Ingelheim.
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