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The Latest Breaking News from Food and Drug Administration

The FDA finally approved Elon Musk's Neuralink chip for human trials. Have all the concerns been addressed?

Since its founding in 2016, Elon Musk’s neurotechnology company Neuralink has had the ambitious mission to build a next-generation brain implant with at least 100 times more brain connections than devices currently approved by the US Food and Drug Administration (FDA).

The Conversation

Gay men can now donate blood after FDA changes decades-old rule – a health policy researcher explains the benefits

The U.S. Food and Drug Administration announced on May 11, 2023, that it has officially dropped restrictions that prohibit gay and bisexual men from donating blood under many circumstances on May 11, 2023. The ban was initially put in place in the early days of the AIDS epidemic, but for…

The Conversation

New blood donation rules allow more gay men to give in US

New blood donations rules will allow sexually active gay and bisexual men in monogamous relationships to give in the U.S. The Food and Drug Administration guidelines ease decades-old restrictions on blood donations put in place to protect the blood supply from HIV

The Independent UK

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The FDA considers first birth control pill without a prescription

The Food and Drug Administration is weighing whether to allow a birth control pill to be sold over the counter for the first time. An advisory committee opens a two-day hearing Tuesday.

WEKU

FDA approves 1st RSV vaccine

The Food and Drug Administration has approved a vaccine for respiratory syncytial virus (RSV) for use in people ages 60 and older.

LiveScience

World's first respiratory syncytial virus vaccine gets approval: Key points to know

Pharmaceutical company GSK's RSV vaccine has been approved by the US Food and Drug Administration (FDA) to become the world's first such vaccine. Known as Arexvy, this vaccine has been approved after three clinical trials.

The Times of India

FDA approves 1st pill made from human poop

The Food and Drug Administration approved the second-ever medical treatment made from donated human feces.

LiveScience

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Abortion pill access preserved — for now — by Supreme Court

The justices granted emergency requests from the Biden administration and Danco Laboratories, maker of the drug mifepristone. They are appealing a lower court ruling that would roll back Food and Drug Administration approval of mifepristone.

Chicago Sun-Times

Supreme Court set to decide on access to abortion pill

The Supreme Court is facing a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved

The Independent UK

US Supreme Court temporarily extends access to abortion pill

The Supreme Court has temporarily extended women's access to an abortion pill until Friday while the justices consider whether to allow restrictions on mifepristone to take effect as a legal challenge to the medication's Food and Drug Administration approval continues.

France 24

Supreme Court preserves FDA rules for access to abortion pill – but only temporarily

The decision that overturned the FDA’s approval of mifepristone is on hold as the nation’s high court considers the case

The Independent UK

All eyes on SCOTUS for abortion pill ruling

A decision could come Friday — and could effectively override the Food and Drug Administration's decision-making.

Axios

Appeals court allows limited access to abortion pill

A federal appeals court partly granted the Biden administration’s request to put on hold a Texas court ruling overturning FDA approval of the abortion pill, but allowed restrictions that were lifted since 2016 to be reinstated.

Tribune News Service

Lisa Jarvis: Abortion pill ruling threatens pharmaceutical innovation

A Texas federal judge’s ruling to remove the 23-year-old drug mifepristone from the market not only threatens abortion access in the U.S. — it’s also an appalling sideswipe at the Food and Drug Administration’s authority and expertise.

Tribune News Service

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Tribune News Service

Abortion drug rulings spur drugmaker worries about precedent

WASHINGTON — Experts worry two recent rulings challenging the Food and Drug Administration’s regulation of a drug used in medication abortions threaten to complicate the agency’s oversight and the pipeline for future research and drug approvals.

Chicago Sun-Times

Ask the Doctors: Botox injections one way to treat excessive sweating

Hyperhidrosis is excessive perspiration that isn’t associated with exercise, temperature or other typical triggers.

The Independent UK

Eyedrops maker couldn't ensure factory was sterile, FDA says

The Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops

Tribune News Service

Cynthia M. Allen: Texas abortion pill case is no morality play. It’s a complex, technical squabble

Since a group of pro-life plaintiffs first challenged the Food and Drug Administration’s approval of mifepristone, one of the two drugs used in chemical or medication abortions, the reporting on the case has been predictable.

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Reason

Should Scientists Use "Race" as a Proxy for Genetics?

Nature, last month (paywall): The US Food and Drug Administration (FDA) will soon require [based on new federal legislation] researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants…. The diversity requirement arrives in the wake of a 2022 report from…

Chicago Tribune

Commentary: Banning abortion pill mifepristone would be a terrible policy choice and violate human rights

Patients’ access to lifesaving medicine is under threat because an anti-abortion rights organization sued in federal district court to overrule the Food and Drug Administration’s approval of mifepristone, which has been used to terminate early pregnancies for almost a quarter century in the U.S. If the judge, appointed by the…

Chicago Sun-Times

Oat and soy can be called milk, FDA proposes

Dairy producers for years have called for the FDA to crack down on plant-based drinks and other products that they say masquerade as animal-based foods and cloud the real meaning of “milk.”

WEKU

FDA has new leverage over companies looking for a quicker drug approval

The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.

Fortune

An FDA panel has recommended a 2-dose RSV vaccine for older Americans. Here’s when they might be able to get it

The jabs could be ready as soon as this summer, one expert tells Fortune.

Tribune News Service

An at-home COVID-19 and flu test gets FDA emergency use authorization

The Food and Drug Administration has approved an at-home test that can detect and discern between COVID-19 infection and two strains of the flu, Influenza A and B, continuing the shift from clinical to home-diagnostic care that blossomed during the height of the pandemic.

Tribune News Service

Noah Feldman: New pro-choice abortion pill lawsuit is a gamble

As a Texas federal judge mulls whether to halt the Food and Drug Administration’s longstanding approval of an abortion pill, 12 liberal states have filed a separate lawsuit in a federal district court in Washington state that seeks to force the FDA to drop some restrictions on the drug.

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