Tag: FDA Food and Drug Administration

FDA Grants Full Approval for New Alzheimer’s Drug that Slows Progression of the Disease

Last week, the Food and Drug Administration (FDA) fully approved the Alzheimer’s drug Leqembi, amid some concerns about its safety, cost and accessibility.  The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. Other approved drugs only target its symptoms. About 6.7 million adults ages […]

Makers of Ozempic and Wegovy File Multiple Lawsuits over Compounded, Off-Brand Versions

Novo Nordisk, the pharmaceutical company that makes Ozempic and Wegovy, filed multiple lawsuits last week against off-brand versions of the wildly popular drugs. In a press release, the company announced that legal action is being taken against certain medical spas, weight loss or wellness clinics, and compounding pharmacies for “the unlawful marketing and sales of non-FDA approved […]

AI is a “Game Changer” when it comes to Early Breast Cancer Detection

Hungarian physicians are using an artificial intelligence model that can detect breast cancer four years before it develops, The New York Times reported March 7. Called computer-assisted detection, the AI identifies spots in mammograms for physicians to inspect closely. An MIT study found the technology was able to identify changes between mammograms and detect spots that were […]

FDA grants full approval to Paxlovid to treat Covid in high-risk adults

On Thursday, the Food and Drug Administration granted full approval to Pfizer’s Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus. Paxlovid is specifically advised for the treatment of mild to moderate Covid in adults older than 50 and people who suffer from certain medical conditions that place them at a higher risk of ending […]

FDA Votes Unanimously to Approve Over-The-Counter Birth Control Pills

Last week, advisers for the US Food and Drug Administration voted unanimously in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks. Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able […]

New Dementia Drug Lauded as “the beginning of the end” for Alzheimer’s Disease

The best ever drug for Alzheimer’s disease has been found to slow decline by a third, in a breakthrough that ushers in a new era of treatment for dementia. On May 3, US pharmaceutical giant Eli Lilly announced that its drug donanemab delays the worsening of symptoms by 35 per cent. In half of patients, the drug completely […]

Major Akorn Company Drug Recall for both People and Pets

Check any prescription or over-the-counter drugs taken by you or your pets. If any of them carry the Akorn brand or were made by Akorn for another brand, that medication got recalled Wednesday. Akorn makes over-the-counter and prescription drugs for people and pets, some of which get repackaged by private brands. Their array of products […]

FDA says the Infected Eye Drops Manufacturer couldn’t ensure their Factory was “Sterile”

The manufacturer of eyedrops recently linked to deaths and injuries lacked measures to assure sterility at its factory in India, according to U.S. health inspectors. As NBC News reports, Food and Drug Administration (FDA) officials uncovered about a dozen problems with how Global Pharma Healthcare made and tested its eyedrops during an inspection from late February through early March. […]

DEA warns that deadly Tranq-contaminated Fentanyl is now in 48 States

The US Drug Enforcement Administration (DEA) is warning the public about a sharp increase in trafficking in fentanyl mixed with the animal tranquilizer xylazine, stating that the agency has seized mixtures of the deadly drug combo in 48 states. The DEA warning comes on the heels of a US Food and Drug Administration (FDA) announcement that it would begin […]

Rising Deaths and Vision Loss linked to Contaminated Eye Drops

The death toll of an outbreak linked to contaminated recalled eye drops has risen and more people have lost their vision. As ABC News reports, an update issued by the Centers for Disease Control and Prevention on Tuesday stated that the number of deaths has risen from one — which occurred in Washington state — to three. What’s more, […]