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FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilar Otulfi (ustekinumab-aauz)
LAKE ZURICH, Ill., May 19, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S Food and...
FDA Approves Nuvaxovid (COVID-19 Vaccine, Adjuvanted) to Prevent COVID-19
Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for...
Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States
(BUSINESS WIRE)--May 15, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved...
Pulmonary Embolism More Common in Children Than Previously Thought
Pulmonary embolism (PE) is more common in children than previously thought, according to a study presented at the American Thoracic Society 2025 International...
Mortality, Sudden Cardiac Death Higher for Male Professional Bodybuilders
The risks for death and sudden cardiac death (SCD) are higher for male bodybuilders than amateurs, according to a study published online May 20 in the...
Abbreviated Breast MRI Has High Diagnostic Accuracy for Dense Breasts
For women with extremely dense breasts who are negative for cancer at mammography, abbreviated breast magnetic resonance imaging (MRI) for first-round...
Herpes Simplex Virus Type 1 May Affect Risk for Alzheimer Disease
Herpes simplex virus type 1 (HSV-1) is associated with an increased risk for Alzheimer disease (AD) based on real-world data from the United States, according...
FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines
THURSDAY, May 22, 2025 — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines.The...
Sugar, Fat and Salt on the Rise in U.S. Breakfast Cereals, Study Shows
THURSDAY, May 22, 2025 — They’re a go-to breakfast for millions of kids and adults. They’re brightly colored, packed in enticing boxes and often...
China Donates $500M to WHO as U.S. Pulls Back Support
THURSDAY, May 22, 2025 — China has promised to give $500 million to the World Health Organization (WHO) over the next five years, positioning itself...
Donor Hearts Might Be Kept Healthy In Cold Storage Longer
THURSDAY, May 22, 2025 — More donor hearts could become available for transplant, thanks to a new discovery that could protect them from damage during...
Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea
CAMBRIDGE, Mass., May 19, 2025 – Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates...
Global Phase III Trials Demonstrate That Nerandomilast Slowed Lung Function Decline in IPF and PPF, with Similar Discontinuation Rates to Placebo
Ingelheim, Germany, May 19, 2025 - Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD...
Toxic Metals Found in All Rice Samples in New Study
FRIDAY, May 16, 2025 — A new report says rice sold in U.S. stores contains toxic heavy metals, including arsenic, cadmium, lead and mercury. The...
FDA Drug Safety Communication: FDA Requires Warning About the Risk of Pruritus After Stopping Long-Term Use of Cetirizine or Levocetirizine
FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal,...
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Latest FDA New Drug Approvals
- Nuvaxovid Nuvaxovid (COVID-19 Vaccine, Adjuvanted) is a protein-based, non-MRNA vaccine for active immunization to prevent coronavirus disease 2019...
- Emrelis Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous...
- Avmapki Fakzynja Co-Pack Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...
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