News Archives - Page 39 of 41

July 8, 2023 Artificial Intelligence FDAcop

FDA Updates: June 16, 2023

The U.S. Food and Drug Administration (FDA) has provided an at-a-glance summary of news from around the agency. Here are some key highlights: 1. COVID-19 Vaccine Formulation for Fall/Winter 2023-2024: The FDA has advised COVID-19 vaccine manufacturers to develop vaccines with a monovalent XBB.1.5 composition for the upcoming fall and winter seasons. The agency expects […]

July 8, 2023 Artificial Intelligence FDAcop

Exclusive Article – Expressing Gratitude

A new report from the E.U. Big Data Steering Group (BDSG), EMA, and the European Medicines Regulatory Network (EMRN) shares experience obtained from real-world data (RWD) based studies between September 2021 and February 2023. The aim of the study was to establish a workable framework for using real-world evidence (RWE) for regulatory cases within the […]

July 8, 2023 Artificial Intelligence FDAcop

FDA Initiates Pilot Program to Mitigate Risks in Utilizing Laboratory Developed Tests for Cancer Biomarker Identification

The U.S. Food and Drug Administration (FDA) has launched a new voluntary pilot program aimed at improving the selection of cancer treatments for patients. The program focuses on certain oncology drug products used with corresponding in vitro diagnostic tests. These tests provide essential information for the safe and effective use of specific cancer treatments. The […]

July 7, 2023 Artificial Intelligence FDAcop

Latest FDA Updates: July 7, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates from the agency. One of the highlights is “Operation Broader Sword”, a joint enforcement operation between the U.S. and the Government of India to identify and stop the shipment of illicit pharmaceuticals, devices, and precursor chemicals through the international […]

July 7, 2023 Artificial Intelligence FDAcop

Recap of FDA Updates: June 20, 2023

The U.S. Food and Drug Administration (FDA) has released an at-a-glance summary of recent news and updates from the agency. One of the key updates is the FDA’s report on the occurrence of foodborne illness risk factors in fast food and full-service restaurants. According to the Centers for Disease Control and Prevention (CDC), over half […]

July 7, 2023 Artificial Intelligence FDAcop

FDA Gives Approval for New Class of Medications to Treat Type 2 Diabetes in Pediatric Patients

The U.S. Food and Drug Administration (FDA) has approved two medications, Jardiance and Synjardy, as treatment options for children aged 10 and older with type 2 diabetes. This is significant, as children with type 2 diabetes have limited treatment options compared to adults. Type 2 diabetes is a chronic condition where the body does not […]

July 7, 2023 Artificial Intelligence FDAcop

FDA Issues Over 180 Warning Letters to Retailers Selling Youth-Appealing Elf Bar and Esco Bars E-Cigarettes in Wake of Inspection Blitz

The U.S. Food and Drug Administration (FDA) has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors known to appeal to youth, such as bubblegum and cotton candy. The FDA is committed to using all of its […]

July 7, 2023 Artificial Intelligence FDAcop

FDA Grants Traditional Approval for Novel Alzheimer’s Disease Treatment

The U.S. Food and Drug Administration (FDA) has converted the drug Leqembi (lecanemab-irmb) from accelerated approval to traditional approval for the treatment of Alzheimer’s disease. This decision was made after a confirmatory trial showed that the drug provides clinical benefit. Leqembi is the first amyloid beta-directed antibody to receive traditional approval for Alzheimer’s disease. The […]

July 7, 2023 Artificial Intelligence FDAcop

FDA Grants Full Approval to Eisai’s Alzheimer’s Drug, but Issues Stronger Safety Alert

Eisai, a Tokyo-based pharmaceutical company, has received full FDA approval for its Alzheimer’s disease drug, Leqembi. This decision not only marks a significant milestone for the treatment of Alzheimer’s but also sets a precedent for the review and potential approval of other therapies for the neurodegenerative disorder. Leqembi is an antibody that targets the buildup […]

July 6, 2023 Artificial Intelligence FDAcop

FDA Gives Green Light to First Gene Therapy for Select Patients with Duchenne Muscular Dystrophy

On June 22, 2023, the U.S. Food and Drug Administration (FDA) approved Elevidys, the first gene therapy for the treatment of pediatric patients aged 4 to 5 years with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene and are eligible for the therapy. This approval addresses an urgent medical need […]

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