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The Latest Breaking News from FDA

CDC to investigate possible link between updated Pfizer Covid vaccine and increased stroke risk among over-65s

'It is very unlikely that the signal would represent a true clinical risk, we believe it is important to share this information with the public'

Wales Online

Biden COVID-19 adviser Kessler to depart as pandemic wanes

WASHINGTON — David Kessler, a former FDA commissioner who helped steer President Joe Biden’s COVID-19 policy, will leave the administration — as the government’s response continues to gear down amid a waning pandemic and a funding crunch.

Tribune News Service

Great Moments in Unintended Consequences (Vol. 10)

Good intentions, bad results

Reason

From analysis to the latest developments in health,
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What the FDA's accelerated approval of a new Alzheimer's drug could mean for those with the disease – 5 questions answered about lecanemab

The U.S. Food and Drug Administration approved the medication lecanemab, sold under the brand name Leqembi, on Jan. 6, 2023, through an “accelerated approval pathway” that fast-tracks promising clinical treatments for diseases in which there are no other currently effective options.

The Conversation

Lisa Jarvis: Obesity drugs for kids? Why new guidelines make sense

A leading organization of pediatricians is recommending that teens with obesity be offered weight-loss medication as part of a comprehensive treatment plan. But unless barriers to access fall, it won’t move the needle on the U.S. childhood obesity epidemic — something that affects more than 1 in 5 kids in…

Tribune News Service

The FDA no longer requires all drugs to be tested on animals before human trials

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

WEKU

Alabama attorney general could prosecute women who take abortion drugs. Opponents say it’s ‘plainly unlawful’

Steve Marshall says abortion patients could be prosecuted under a ‘chemical endangerment’ law, marking the first time the state’s top law enforcement official has targeted pregnant people in anti-abortion campaign

The Independent UK

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What the FDA's rule changes allowing the abortion pill mifepristone to be dispensed by pharmacies mean in practice – 5 questions answered

In early January 2023, the U.S. Food and Drug Administration modified its rules for mifepristone, a drug used for medication abortion, allowing it to be offered with a prescription by certified pharmacies. Before this rule change, mifepristone could be dispensed only in person by providers at hospitals, clinics and medical…

The Conversation

Editorial: Delay in making naloxone an over-the-counter drug to counter opioid overdoses was deadly

It's been six years since a startling story in The New York Times detailed how fatal opioid overdoses were tearing through rural regions of the United States "like a plow through soil." The report came as the nation was beginning to grasp that it faced the deadliest wave of drug…

Tribune News Service

Commentary: Abortion pills in pharmacies are the future. But the FDA should do more to expand access

On Jan. 3, the U.S. Food and Drug Administration took a first step toward making abortion pills available at retail pharmacies. It released new rules outlining how both bricks-and-mortar and mail-order pharmacies can get certified to dispense mifepristone, the first pill in a medication abortion. But the agency also left…

Los Angeles Times

Mayo Clinic expert provides perspective on FDA approval of another experimental Alzheimer's drug

The Food and Drug Administration granted accelerated approval of a disease-modifying treatment that could potentially give some patients with Alzheimer's disease something they haven't had before: a medication that may slow the decline of memory and thinking.

Tribune News Service

How the pharmaceutical industry uses disinformation to undermine drug price reform

Canada’s drug prices are the fourth highest in the developed world. Despite this, Innovative Medicines Canada (IMC), the lobby group for Big Pharma, put out a call in November 2022 for the Canadian government to suspend consultations on guidelines aimed at lowering prescription drug prices.

The Conversation

Finally, a new drug slows Alzheimer’s, but is it worth the price for modest benefit?

Leqembi can slow early progression by months but has safety concerns. Most patients will likely have to wait months to get the IV drug, which will cost about $26,500 a year. Insurers need to decide whether and how much to cover it. Medicare isn’t expected to pay for it until…

Chicago Sun-Times

Editorial: The FDA is right to allow pharmacies to distribute abortion medication

Precisely when human life begins is above our pay grade, but at a time when states are radically restricting women’s right to seek reproductive health care — and forcing rape and incest victims, among others, to give birth — policymakers in Washington ought to be wisely using the levers of…

Tribune News Service

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The Independent UK

EXPLAINER: New drug slows Alzheimer's but comes with caveats

A new Alzheimer’s drug is hitting the market with experts voicing a lot of caution

Tribune News Service

Commentary: New FDA rules on abortion pills leave too many hurdles

Recent decisions by the U.S. Food and Drug Administration and the two biggest pharmacy chains are bringing the post-Roe v. Wade landscape more clearly into focus. America is becoming a country where abortion is a crime in some states but just a normal part of health care in others.

Asharq Al-Awsat

US Approves New Drug to Treat Alzheimer's Disease

The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer's disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized…

The Philadelphia Inquirer

The FDA approved the first Alzheimer’s drug that may really work. A Penn physician explains why you probably can’t get it, yet

The FDA on Friday authorized the use of the Alzheimer’s drug lecanemab, the first drug clearly shown to slow the progress of the debilitating brain disease.

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WEKU

FDA approves Alzheimer's drug that appears to modestly slow disease

An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.

The Independent UK

Alzheimer’s drug that slows disease progression approved by FDA

U.S. health officials have approved a new Alzheimer’s drug that modestly slows the brain-robbing disease

Axios

FDA grants fast-track approval to experimental Alzheimer's drug

The FDA approved lecanemab, which has shown to slow the progression of Alzheimer's disease.

The Independent UK

Alzheimer's drug that modestly slows disease OK'd by FDA

U.S. health officials have approved a new Alzheimer’s drug that modestly slows the brain-robbing disease

Salon

What FDA's abortion pill changes mean

Walgreens and CVS can now sell the abortion pill — but will they?

The Independent UK

NOT REAL NEWS: A look at what didn't happen this week

Social media users shared a range of false claims this week

Axios

2023 could be a banner year for prescription drugs

There's a large pipeline of promising yet expensive drugs that could get approved.

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