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The Latest Breaking News from FDA

Ascendis Stock Plunges As FDA Identifies Deficiencies In Company's New Drug Application

The FDA decision prevents Ascendis from labeling and marketing the new drug application for TransCon PTH. ASND stock plunged.

Investors Business Daily

This Dental Device Was Sold to Patients To Fix Their Jaws — Now, Their Smiles Are Warped

Boja Kragulj, an accomplished clarinetist who once performed with orchestras in New York, Philadelphia, and Jacksonville, Florida, has already lost four teeth.

Inverse

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.

Tribune News Service

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7 key questions about worsening drug shortages, answered

More Americans are queuing up at pharmacies and discovering they can't get the critical medicines they've been prescribed.

Los Angeles Times

Youth activists in Michigan urge statewide ban on flavored tobacco products

DETROIT — Kassie Weje, a 16-year-old junior at University High School in Ferndale, said her little sister was first exposed to other kids vaping at school when she was in fifth grade.

Tribune News Service

FDA evaluates ‘safety concerns’ over dental devices featured in KHN-CBS investigation

In the wake of a KHN-CBS News investigation, the FDA on Thursday said it is “evaluating safety concerns” over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients.

Tribune News Service

Narcan: the life-saving nasal spray that reverses opioid overdoses

A nasal spray that reverses opioid overdoses is set to become the first opioid treatment drug to be sold over the counter in the US.

The Week

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The FDA now requires medical devices be secured against cyberattacks

Critical vulnerabilities in Internet-connected medical devices lead to new FDA cybersecurity protection measures.

TechRadar

Senators Ask DEA To Stop Buying Its Way Around Civil Liberties

Plus: Senate Republicans spar over TikTok and free speech, Americans can't agree on how to cut spending, and more...

Reason

FDA approves over-the-counter Narcan to combat opioid overdose crisis

The U.S. Food and Drug Administration has approved a naloxone nasal spray for over-the-counter use.

LiveScience

Why over-the-counter Narcan may not reach those most in need

If insurers or governments don't step up, addiction experts fear it could widen health disparities and undercut the FDA's goals of addressing a "dire public health need."

Axios

An Overdose Antidote Is Coming to a Drug Store Near You: “Be Ready To Save a Life”

On Wednesday, the FDA approved Narcan for over-the-counter use in the form of a nasal spray, previously available only by prescription.

Inverse

Blac Chyna says she could have died from illegal butt injections after procedure to remove silicone

‘My rear end would get super inflamed and it would get really really hard and really hot,’ she said about side effects of injections

The Independent UK

FDA approval of over-the-counter Narcan is an important step in the effort to combat the US opioid crisis

On March 29, 2023, the U.S. Food and Drug Administration approved Narcan for over-the-counter sale. Narcan is the 4-milligram nasal spray version of naloxone, a medication that can quickly counteract an opioid overdose.

The Conversation

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Reason

Blue-State AGs Have A Mifepristone Lawsuit of Their Own

And this lawsuit faces many of the same administrative law hurdles as does AHM v. FDA.

Chicago Sun-Times

Overdose antidote Narcan to be sold over the counter, FDA says

The spray version of naloxone will be available for sale by late summer. Experts praised the move to make it more accessible amid the national opioid crisis but are concerned it may be too expensive for some people.

Reason

FDA Will Finally Let You Get Naloxone Over the Counter

The life-saving drug stops opioid overdoses as they happen, restoring breathing and preventing death. Why did it take so long for the FDA to expand its use?

Tribune News Service

FDA approves first over-the-counter anti-overdose Narcan spray

The U.S. Food and Drug Administration announced Wednesday that it had approved Narcan for over-the-counter, nonprescription use.

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Al Jazeera

US approves sale of overdose reversal drug without prescription

The decision comes as a bid to widen access to the life-saving drug as the US struggles with a wave of overdose deaths.

WEKU

The FDA may soon authorize a spring round of COVID-19 boosters for some people

The Food and Drug Administration appears poised to make available the COVID-19 vaccines that target omicron as a second booster for people with weak immune systems and those ages 65 and older.

StockNews.com

3 of the Best Stocks in 1 of Wall Street's Worst-Rated Industry

After years of robust growth, the biotech industry has struggled since last year due to several headwinds, including regulatory concerns, inflation, and the Fed’s aggressive rate hikes, which have sucked out speculative capital. Despite currently being one of the poorly-rated industries, investors could consider buying top-biotech stocks Gilead (GILD), Vertex…

WEKU

The FDA approves the overdose-reversing drug Narcan for over-the-counter sales

The decision could make the life-saving drug more accessible. Emergent BioSolutions, the drug company that produces Narcan, said it anticipates it will be on store shelves by late summer.

The Independent UK

FDA approves over-the-counter Narcan. Here’s what it means

The U.S. Food and Drug Administration has approved selling overdose antidote naloxone over-the-counter, marking the first time a opioid treatment drug will be available without a prescription

The Independent UK

FDA approves over-the-counter Narcan. Here's what it means

The U.S. Food and Drug Administration has approved selling overdose antidote naloxone over-the-counter, marking the first time a opioid treatment drug will be available without a prescription

Los Angeles Times

Robin Abcarian: Relax, candy lovers. No one is trying to ban Skittles. Well, not exactly

Scratch the surface of a Skittles and, wow, you will find so much more than a chewy fruit-flavored sugar bomb. The shiny candy is a bit like a Rorschach test; you see what you want to see in those rainbow-colored morsels.

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