FDA Approvals Archives

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 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.

FDA Approves More Vaping Products

May 5, 2026 | FDA Approvals, Nicotine Alternatives, Vaping & E-Cigarettes

The FDA authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application pathway.

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.

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 Expanded Indications for CF Drugs Alyftrek, Trikafta

Apr 1, 2026 | Cystic fibrosis, FDA Approvals, US Pharmaceuticals

New label extensions for Alyftrek and Trikafta make approximately 95% of the cystic fibrosis population in the United States eligible for treatment.

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 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 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.

FDA Approves Ultra-long-acting Biologic Depemokimab for Severe Asthma

Dec 23, 2025 | Asthma, FDA Approvals, US Pharmaceuticals

Depemokimab is a twice-yearly administered monoclonal antibody approved for patients with severe asthma with an eosinophilic phenotype.

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.

FDA Approves Augmentin XR Antibiotic as Part of National Priority Voucher Pilot Program

Dec 15, 2025 | FDA Approvals, US Pharmaceuticals

The US FDA approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program.

FDA Approves Albuterol Sulfate Inhalation Aerosol from Amneal

Dec 2, 2025 | FDA Approvals, US Pharmaceuticals

Amneal Pharma’s new albuterol sulfate inhalation aerosol offers a generic equivalent for Teva’s ProAir HFA.

FDA Approves Hyrnuo (sevabertinib) for Certain NSC Lung Cancer Patients

Nov 24, 2025 | FDA Approvals, Lung Cancer, US Pharmaceuticals

Hyrnuo is now indicated for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) TKD activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

FDA Tentatively Approves Generic Beclomethasone Dipropionate HFA Inhalation Aerosol

Oct 30, 2025 | FDA Approvals, US Pharmaceuticals

Amneal Pharma’s new Beclomethasone Dipropionate HFA Inhalation Aerosol offers a generic equivalent for Teva’s Qvar.

FDA Expands Winrevair Approval for Pulmonary Arterial Hypertension

Oct 27, 2025 | FDA Approvals, Pulmonary Hypertension, US Pharmaceuticals

Winrevair is now FDA-approved to treat pulmonary arterial hypertension to improve exercise capacity and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.

Asahi Kasei Expands Critical Care Solutions with FDA-approved Zoll Zenix Monitor/Defibrillator

Oct 17, 2025 | FDA Approvals, Therapy Devices

Zoll (an Asahi Kasei company) recently announced its Zenix monitor/defibrillator received premarket approval by the US FDA.

Category: FDA Approvals

FDA Approvals

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 Approves Benralizumab for Hypereosinophilic Syndrome

FDA Approves More Vaping Products

FDA Approves Breztri for Asthma Patients 12+

FDA Approves IPF Generic Nintedanib

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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 Approves Benralizumab for Hypereosinophilic Syndrome

FDA Approves More Vaping Products

FDA Approves Breztri for Asthma Patients 12+

FDA Approves IPF Generic Nintedanib

FDA Approves Expanded Indications for CF Drugs Alyftrek, Trikafta

FDA Approves Age Limit Removal for Neffy Epinephrine Nasal Spray

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

FDA Advances Biosimilar Pharma Development

FDA Approves First Flovent Generic for Asthma

FDA Launches PreCheck Pilot Program for Pharmaceuticals

FDA Guidance to Update Clinical Trials

FDA Approves Ultra-long-acting Biologic Depemokimab for Severe Asthma

FDA Approves Jascayd/Nerandomilast for Progressive Pulmonary Fibrosis

FDA Eliminates Limitation on Real-World Evidence

FDA Approves Augmentin XR Antibiotic as Part of National Priority Voucher Pilot Program

FDA Approves Albuterol Sulfate Inhalation Aerosol from Amneal

FDA Approves Hyrnuo (sevabertinib) for Certain NSC Lung Cancer Patients

FDA Tentatively Approves Generic Beclomethasone Dipropionate HFA Inhalation Aerosol

FDA Expands Winrevair Approval for Pulmonary Arterial Hypertension

Asahi Kasei Expands Critical Care Solutions with FDA-approved Zoll Zenix Monitor/Defibrillator

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