Valneva: Chikungunya Candidate Submission Application for FDA Completed

02/20/2023, 787 characters The US Food and Drug Administration (FDA) has completed a submission review of Valneva’s biologics license application for single-shot chikungunya vaccine candidate VLA1553 and determined that the application is sufficiently complete to permit a substantive review. The review classification is “priority,” Valneva says. According to Valneva, late August 2023 has been assigned … Read more

FDA approves first drug to treat eye disorder to prevent blindness

Written by Amal Allam Saturday, February 18, 2023 12:15 PM The US Food and Drug Administration said:FDAShe agreed to a company drug Called Pharmaceuticals To treat an advanced eye disorder that is one of the leading causes of blindness worldwide. According to Archyde.com, the drug slowed the progression of geographical atrophy of the eye(GA) It … Read more

Due to possible E. Coli, frozen falafel is recalled in the US; report 5 hospitalizations | Healthy world

The Centers for Disease Control and Prevention (CDC) as well as the United States Food and Drug Administration (FDA) reported on the voluntary recall of the Falafel product Traditional Vegan Soil Grown and Garlic & Herb Falafel Distributed and Sold Exclusively by Aldi, Batavia, IL due to the possible presence of E. coli. Through a … Read more

FDA warns 7 companies that sell nutritional supplements claiming they treat heart disease

The US Food and Drug Administration issuedFDAWarning letters to 7 companies for illegally selling dietary supplements that claim to treat, mitigate, or prevent cardiovascular disease, or related conditions, such as atherosclerosis, stroke, or heart failure, in violation of the Federal Food, Drug and Cosmetic Act, and that According to the site “FDA“. Warning to consumers … Read more

LG Chem acquires US anti-cancer bio company for 800 billion won

[메디칼업저버 손형민 기자] LG Chem announced that it has decided to acquire Aveo Pharmaceuticals, which owns the US Food and Drug Administration (FDA)-approved kidney cancer treatment ‘Potivda (ingredient name: tivozanib)’ for $566 million (about 800 billion won). This is the first time for a Korean company to acquire a company with an FDA-approved new drug, … Read more

[Health 1+1]What are the pros and cons of the FDA Prescription Drug Applicant Fee Act? | Drug Review | US Act | Live

The FDA was established in 1906, and its main functions are to supervise and manage food, drugs, vaccines, blood preparations, medical equipment, veterinary drugs and cosmetics in the United States. During this period, what did the FDA do for the American people to be proud of, and what were the shortcomings? Which amendments or enactments … Read more

Key medicine to prevent malaria obtains WHO prequalification – Health

With the support of UNITAID* and Medicines for Malaria Venture Universal, the company Corporation Ltd (UCL) became the first African manufacturer to obtain World Health Organization (WHO) prequalification for a key medicine to prevent malaria in pregnant women and children. Prequalification is a service provided by the WHO to assess the quality, safety and efficacy … Read more