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The Latest Breaking News from the Food and Drug Administration

Magistrate Judge/Zoologist Recommends Dismissal of Drug Company's Libel Claim Against Scientists

An excerpt from a long report and recommendation released Wednesday by Magistrate Judge Ona Wang (S.D.N.Y.) in Cassava Sciences, Inc. v. Bredt; for more details, read the whole opinion: At various dates in 2021, the Neuroscientist Defendants filed a Citizen Petition and sent publicly available letters to the Food and…

Reason

FDA approves Florida's plan to import cheaper drugs from Canada

The Food and Drug Administration's authorization of Florida's plan to import prescription medicines from Canada is a first. But the state still has hurdles to clear before imports could begin.

WEKU

A Doctor And Mother's Plea To FDA To Help Save Children With Rare Disease

Despite what appears to be a major medical breakthrough on treatments for Sanfilippo, the Food and Drug Administration has refused to funnel the medicine through a faster approval process.

International Business Times

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Sickle cell patient's journey leads to landmark approval of gene-editing treatment

In early December, the Food and Drug Administration approved a gene-editing treatment for sickle cell disease, the first for any illness. One patient helped pave the way.

WEKU

FDA finds 'extremely high' lead levels in cinnamon at Ecuador plant that made tainted fruit pouches

U.S. food inspectors found “extremely high” lead levels in cinnamon at a plant in Ecuador that made applesauce pouches tainted with the metal

The Independent UK

The FDA is investigating whether lead in applesauce pouches was deliberately added

The Food and Drug Administration is working with Ecuadorian authorities to investigate Negasmart, who has been supplying cinnamon to the three recalled applesauce brands.

WEKU

When authoritative sources hold onto bad data: A legal scholar explains the need for government databases to retract information

In 2004, Hwang Woo-suk was celebrated for his breakthrough discovery creating cloned human embryos, and his work was published in the prestigious journal Science. But the discovery was too good to be true; Dr. Hwang had fabricated the data. Science publicly retracted the article and assembled a team to investigate…

The Conversation

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Supreme Court to hear abortion pill case

The court's action sets up a collision between the Food and Drug Administration's 23-year study and supervision of mifepristone, and the circumstances under which it can be prescribed.

WEKU

FDA approves first gene-editing treatment for human illness

The Food and Drug Administration approved two genetic treatments for sickle cell disease, including one that uses gene-editing. The approvals offer hope for patients and signal a new medical era.

WEKU

Eli Lilly Stock Nears Another Record As Drugmaker Enters The Weight-Loss Arena

Eli Lilly stock is Monday's IBD Stock Of The Day. Shares are forming a new flat base after the FDA approved Lilly's new weight-loss drug.

Investors Business Daily

Why are we still eating Red Dye No. 3?

The synthetic dye is present in hundreds of candies, as well as snacks like Ding Dongs and Peeps

Salon

Novavax Surges After FDA Signs Off On Its Updated Covid Shot, Joining Pfizer, Moderna

The Food and Drug Administration signed off on Novavax's updated Covid booster late Tuesday, and NVAX stock surged just before the close.

Investors Business Daily

FDA wants to regulate thousands of lab tests that have long skirted oversight

The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests

The Independent UK

Karuna Takes A Big Step In Schizophrenia Treatment. But Shares Yo-Yo.

Karuna Therapeutics asked the Food and Drug Administration to approve its schizophrenia treatment on Thursday, and KRTX stock rose.

Investors Business Daily

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The Independent UK

FDA skeptical of experimental ALS treatment pushed by patient advocates

The Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease

Investors Business Daily

Alnylam Pharma Tumbles After FDA Advisors Dash Its Hopes Of Rivaling Pfizer

Alnylam stock tumbled Thursday after a split advisory panel recommended the Food and Drug Administration approve its heart disease treatment.

The Independent UK

Joe Biden sends message to Americans on Covid booster shots: ‘Stay up-to-date on vaccines’

US president’s message comes after CDC and FDA decide to recommend Covid booster shots amid rising cases

Dynamite News

US health agency recommends updated COVID boosters, President Biden calls it "important" milestone

he US health agency Centers for Disease Control and Prevention (CDC) on Tuesday authorized, approved, and recommended everyone 6 months and older get an updated COVID-19 booster.

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Chicago Sun-Times

Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug phenylephrine found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.

WEKU

Kentuckians can access FDA, CDC approved new COVID vaccine targeting Omicron subvariants in coming d

As new variants of COVID are making the rounds, the Food and Drug Administration and Centers for Disease Control and Prevention have approved a new round of COVID-19 vaccines.

Investors Business Daily

Novavax Dives As Pfizer, Moderna Snag First Nods For Covid Boosters

Novavax stock crumbled Monday after the Food and Drug Administration signed off on updated Covid boosters from rivals Pfizer and Moderna.

WEKU

New COVID vaccines get FDA approval

Vaccines for a fall immunization drive against COVID-19 just got the green light from the Food and Drug Administration. The agency says the vaccines can protect people, as hospitalizations tick up.

The Independent UK

Sleeping pill could reduce levels of Alzheimer’s proteins

The sleeping pill, known as suvorexant, which has been approved by the Food and Drug Administration (FDA) is used to aid insomnia - now researchers are seeing if it can help slow down Alzheimer’s proteins

The Independent UK

Court revives doctors' lawsuit saying FDA overstepped its authority with anti-ivermectin campaign

A federal appeals court in New Orleans has revived a lawsuit by three doctors who say the Food and Drug Administration overstepped its authority in a campaign against the use of a drug that is not approved to treat COVID-19

The Conversation

FDA's greenlighting of maternal RSV vaccine represents a major step forward in protecting young babies against the virus

With the Food and Drug Administration’s Aug. 21, 2023, approval of the first vaccine against respiratory syncytial virus, or RSV, for use during late pregnancy, the U.S. will soon have a major new tool at its disposal to protect infants against the highly contagious virus.

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