Tag: Food and Drug Administration

Gene Therapies Could Transform Rare Diseases. Are We Holding Them Back?

On Jan. 8, 2020, as I was parking my car, I got a long-awaited phone call from one of my son’s doctors. She informed me that our 7-month-old son, Eliot, had Duchenne muscular dystrophy, a fatal neuromuscular disease. I can still remember the way the Los Angeles winter sunlight hit the dashboard. I can see […]

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CooperSurgical’s Botched IVF Liquid Destroyed Embryos, Lawsuits Claim

CooperSurgical, a major medical supply company, is facing a wave of lawsuits from patients who claim that one of its products destroyed embryos created with in vitro fertilization. Fertility clinics across the world used the product, a nutrient-rich liquid that helps fertilized eggs develop into embryos. This week federal regulators made public that the company […]

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Biogen Abandons Its Controversial Alzheimer’s Drug Aduhelm

The drug maker Biogen said on Wednesday it would abandon its ownership rights to Aduhelm, an Alzheimer’s drug that had provoked fierce criticism of the company and regulators after it was approved based on weak evidence that it would help patients. The company will also stop a clinical trial that the Food and Drug Administration […]

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These Georgia Women Are Suing For Millions Over Hair Relaxers

Black woman getting her hair relaxedPhoto: Vystekimages (Getty Images) New research into the link between cancer and uterine fibroids and chemical hair relaxers has been particularly troubling for Black women — who are more likely to use and be marketed these products than our counterparts. In Georgia, a group of four Black women are suing […]

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These Black Women in Georgia Believe Hair Relaxers Caused Their Health Issues

Black woman getting her hair relaxedPhoto: Vystekimages (Getty Images) New research into the link between cancer and uterine fibroids and chemical hair relaxers has been particularly troubling for Black women — who are more likely to use and be marketed these products than our counterparts. In Georgia, a group of four Black women are suing […]

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Biden Campaign Sharpens Its Post-Roe Message: Abortion Is About Freedom

President Biden and Vice President Kamala Harris will headline events next week centered around protecting abortion rights, throwing more heft behind an issue that has galvanized voters in the 18 months since the Supreme Court struck down Roe v. Wade. On Monday, Ms. Harris will visit Wisconsin to begin a national tour focused on preserving […]

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Quaker Oats Recalls More Products Over Potential Salmonella Contamination

The Quaker Oats Company added more products this week to a recall that started last month over possible salmonella contamination, raising the total number of products to more than 60. Quaker Oats, which is owned by PepsiCo, initially recalled 43 products, including granola bars, cereals and various snack foods. On Thursday, the company added 24 […]

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Federal Scientists Recommend Easing Restrictions on Marijuana

Marijuana is neither as risky nor as prone to abuse as other tightly controlled substances and has potential medical benefits, and therefore should be removed from the nation’s most restrictive category of drugs, federal scientists have concluded. The recommendations are contained in a 250-page scientific review provided to Matthew Zorn, a Texas lawyer who sued […]

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Purina Rebuts TikTok Rumors About Pet Food Safety

Purina has been forced to rebut what it described as “online rumors” that have caused a frenzy on TikTok in recent weeks alleging that its Pro Plan food had sickened dozens of pets, mostly dogs. Days after the company issued a statement in which it said “these false statements may be creating unnecessary stress for […]

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‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials

The young father headed across the parking lot to join the other parents meeting their children’s new preschool teachers. After a few steps, he began sweating and twitching. As the sky reeled, he staggered back to the car, desperate to lie down in the back seat and breathe, hidden by tinted windows. “Did you take […]

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F.D.A. Warned of Mental Side Effects from Asthma Drug, Singulair. Few Were Told.

In early 2020, the Food and Drug Administration responded to decades of escalating concerns about a commonly prescribed drug for asthma and allergies by deploying one of its most potent tools: a stark warning on the drug’s label that it could cause aggression, agitation and even suicidal thoughts. The agency’s label, which was primarily aimed […]

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F.D.A. to Issue First Approval for Mass Drug Imports to States from Canada

The Food and Drug Administration has decided to allow Florida to import millions of dollars worth of medications from Canada at far lower prices than in the United States, overriding fierce decades-long objections from the pharmaceutical industry, according to a senior administration official. The approval is a major policy shift for the United States, and […]

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Florida Health Official Calls for Halt to Covid Vaccines

Florida’s surgeon general on Wednesday called for a halt to the use of Covid vaccines, citing widely debunked concerns that contaminants in the vaccine can permanently integrate into human DNA. “These vaccines are not appropriate for use in human beings,” Dr. Joseph Ladapo, the state’s surgeon general and highest-ranking health official, said in a statement […]

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A Rejected A.L.S. Drug Made Me Rethink the Role of Hope in Medicine

Of all the ways the body can go wrong, A.L.S. is one of the most frightening. It begins subtly — a twitching muscle, a cough when you swallow or a clumsy hand. But then it progresses. Motor neurons degenerate and die. You lose the ability to talk, to eat and ultimately to breathe. There is […]

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We Need to Rethink Our Treatment of Pain

For many years I’ve written about people suffering intractable pain, and how their agony and increased risk of suicide and death has been ignored in the rush to end the overdose crisis. I’ve told the story of a woman who hoped for a cancer diagnosis since it might mean that her chronic pain, which already […]

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Bristol Myers to Acquire the Drugmaker Karuna for $14 Billion

Bristol Myers Squibb, the global pharmaceutical giant, said on Friday that it would acquire Karuna Therapeutics, which makes drugs to treat schizophrenia and Alzheimer’s, in an all-cash deal valued at $14 billion as it looks to strengthen its pipeline of neuroscience drugs. Bristol Myers said in a statement that it would pay $330 per share […]

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Behind the Shortage Keeping Cancer Patients From Chemo

Stephanie Scanlan learned about the shortages of basic chemotherapy drugs this spring in the most frightening way. Two of the three drugs typically used to treat her rare bone cancer were too scarce. She would have to go forward without them. Ms. Scanlan, 56, the manager of a busy state office in Tallahassee, Fla., had […]

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Possible Ways to Ease Drug Shortages

At several congressional hearings this year, ideas to fix drug shortages were as numerous as the number of scarce drugs. The rationing of key chemotherapies added urgency to the crisis. Two of these drugs, carboplatin and cisplatin, are inexpensive and are used to treat up to 20 percent of cancer patients, according to the National […]

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What to Know About the Effects of Ketamine

An autopsy report released by the Los Angeles County medical examiner on Friday said the death of “Friends” actor Matthew Perry, who was found face down and unresponsive in a hot tub at his home on Oct. 28, resulted from the “acute effects” of ketamine, an anesthetic with psychedelic properties. Ketamine has become increasingly popular […]

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Lead Levels in Children’s Applesauce May Be Traced to Cinnamon Additive

With dozens of children across the United States suffering from lead poisoning, federal regulators are now investigating whether the culprit is cinnamon that was added to some popular applesauce pouches, and if lead had been added somewhere along the global supply chain, either to enhance the spice’s reddish color or to add weight. In November, […]

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Supreme Court Will Hear Challenge to Abortion Pill Access

The Supreme Court announced on Wednesday that it would decide on the availability of a commonly used abortion pill, the first major case involving abortion on its docket since it overturned the constitutional right to an abortion more than a year ago. The move sets up a high-stakes fight over the drug, mifepristone, that could […]

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New Sickle Cell Therapies Will Be Out of Reach Where They Are Needed Most

The Food and Drug Administration’s approval on Friday of two groundbreaking gene therapy treatments for sickle cell disease has brought a rare moment of hope and celebration to people with the agonizing blood disorder. But there is no clear path for the new therapies — one-time treatments so effective in clinical trials that they have […]

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F.D.A. Approves Sickle Cell Treatments, Including One That Uses CRISPR

On Friday, the Food and Drug Administration approved the first gene editing therapy ever to be used in humans, a debilitating blood disorder caused by a single mutated gene. The agency also approved a second treatment using conventional gene therapy for sickle cell that does not use gene editing. For the 100,000 Americans with the […]

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White House Delays a Decision on Banning Menthol Cigarettes

The Biden administration delayed a decision on Wednesday about whether it would ban menthol cigarettes amid intense lobbying from tobacco companies, convenience stores and industry-backed groups that contend that billions of dollars in sales and jobs will be lost. The proposal has also generated concerns that Black smokers will become the targets of aggressive police […]

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Why We’re Stuck in a Constant Cycle of Drug Shortages

There’s been a bombardment of bad news for drug supplies. The American Society of Health-System Pharmacists found this summer that nearly all of the members it surveyed were experiencing drug shortages, which generally affect half a million Americans. Cancer patients have scrambled as supplies of chemotherapy drugs dwindle. Other shortages include antibiotics for treatable diseases, […]

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Panera Bread’s Charged Lemonade Linked to Second Death in Lawsuit

A Florida man died after drinking three servings of a heavily caffeinated beverage from Panera Bread, according to a lawsuit filed against the company on Monday. It is the second lawsuit linking the beverage, Charged Lemonade, to a death. Dennis Brown, 46, died in October after suffering a “cardiac event” while walking home from a […]

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CAR-T, Lifesaving Cancer Treatment, May Sometimes Cause Cancer, FDA Says

A Number That Sums It Up: Thousands of lives have been saved with CAR-T. CAR-T involves removing a type of white blood cell — T cells — from a patient’s blood, then genetically engineering to make proteins — chimeric antigen receptors (CAR) — which allow the T cells to attach to cancer cells and kill […]

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Could Longevity Drugs for Dogs Extend Your Pet’s Life?

Longevity drugs are intended for healthy dogs, which changes the risk-benefit calculus. “It’s one thing if a dog is on death’s door and you’re giving them some late-breaking treatment,” said Bev Klingensmith, a Great Dane breeder in Iowa who also has a Great Dane and a golden retriever of her own. “Giving my young, healthy […]

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F.D.A. Approves New Obesity Drug Tirzepatide That Will Compete With Wegovy

The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct competitor to the wildly popular Wegovy. The drug is called tirzepatide and will be sold under the name Zepbound. It joins a class of new medications that are transforming weight loss and obesity, a […]

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Teenage Vaping Declines This Year, Survey Says

What’s Behind the Numbers: Flavor bans may have had an effect. One thing is clear about underage e-cigarette use: Adolescents like flavors. About 90 percent of the students who reported vaping said they used flavored products, citing favorites that tasted like fruit and candy. Teenagers identified Elf Bar and Esco Bar as their favorite brands, […]

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Panel Tells F.D.A. That CRISPR Sickle Cell Cure Is Safe Enough for Patients

A panel of experts said on Tuesday that a groundbreaking treatment for sickle cell disease was safe enough for clinical use, setting the stage for likely federal approval by Dec. 8 of a powerful potential cure for an illness that afflicts more than 100,000 Americans. The Food and Drug Administration had previously found that the […]

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