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The Latest Breaking News from FDA

Michigan baby formula maker resumes production after safety shutdown

The Abbott facility was closed in February after a recall involving bacterial infections in infants which led to a nationwide shortage

The Guardian - US

Abbott restarts baby formula plant linked to contamination

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage

The Independent UK

Some Abbott specialty baby formulas expected in stores later this month

An Abbott plant in Michigan has resumed manufacturing some speciality formulas that are hard to find.

Axios

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Dylan and Will McMahon: brothers behind the UK’s only baby milk producer

The brothers helping run Kendal Nutricare on being ‘best mates’, working with their father and tackling a US shortage

The Guardian - UK

Faye Flam: People, get your booster shots already

Fewer than half of eligible Americans have received a third COVID vaccine shot despite clear evidence of its benefit. That booster shot improves your odds of avoiding even mild omicron. So why haven’t more people gotten it?

Tribune News Service

US FDA Concerned over Potential Novavax Myocarditis Risk

The Food and Drug Administration voiced concern Friday about myocarditis being potentially linked to the Novavax Covid-19 vaccine, just as experts are to weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened…

Asharq Al-Awsat

The FDA is facing an investigation into its handling of the baby formula shortage

The Department of Health and Human Services wants to know if the FDA followed its rules and procedures in investigating the contamination of baby formula and recalling it.

WEKU

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Kansas Patients Now Have Access To Medicinal Cannabis Without A State Law

On June 2, Governor Laura Kelly (D) signed new legislation that would allow Kansans to obtain prescription drugs derived from cannabis-related products.

Benzinga

Amylyx Pharmaceuticals Shares Shoot Up As FDA Extends Review Of NDA For Neurodegenerative Disease Candidate

The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).

Benzinga

Novavax COVID shot effective but carries heart risk, FDA says

Novavax evaluation comes days before key FDA meeting

Axios

The NFL's Recent Investment in Cannabis Signals an Important Evolution in Its Approach to Preventing and Treating Sports Injuries

By Dr. Michael D. Lewis, MD, MPH, Colonel (Retired), U.S. Army, and CV Sciences Medical Advisor

Benzinga

Here's Why Amylyx Pharmaceuticals Shares Are Skyrocketing Today

Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) shares are trading higher by 37.67% at $13.45 after the company announced the FDA extended the review timeline of the New Drug Application for AMX0035.

Benzinga

Ketamine can treat depression — but teletherapy could make it accessible

Opinion: Psychedelic therapy via video conferencing calls could expand accessibility to emerging treatments for depression.

Inverse

Can't Find Baby Formula? Blame Tariffs and the FDA.

This crisis is the result of protectionism, regulation, and central planning.

Reason

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Tribune News Service

The FDA urges people to avoid this TikTok trend with avocados

TikTok has amassed over 1 billion active monthly users worldwide. The fun-loving social media platform is often at the forefront of trends — whether it's the latest dance craze or useful life hacks.

Axios

COVID vaccines for children under 5 possible by June 21, White House says

The FDA and CDC will still need to authorize the shots.

The Independent UK

Contentious CNN interview about baby formula derailed as camera collapses on set

Mr Deese attempted to catch the camera before it tumbled to the ground

Chicago Sun-Times

Ban on menthol cigarettes is the wrong move

Regulation is critical, and Congress recently took a big step forward by raising the tobacco purchasing age to a national standard of 21. But prohibition doesn’t work.

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The Independent UK

Novavax hopes its COVID shot wins over FDA, vaccine holdouts

Americans may soon get a new COVID-19 vaccine option — a more traditional kind of shot known as a protein vaccine

The Independent UK

‘They did, but I didn’t’: Biden denies baby formula makers’ claim shortage was expected in awkward joint briefing

‘I don’t think anyone anticipated the impact of the shutdown of Abbott facility’, Biden says shortly after manufacturers say they expected shortage

Benzinga

Aeglea BioTherapeutics Shares Plummet Following Refusal To File Letter From FDA

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) announced the U.S. Food and Drug Administration (FDA) has refused to accept the company’s Biologics License Application (BLA) with a Refusal to File (RTF) letter.

Benzinga

PDS Biotechnology Gains On FDA Fast Track Designation For Lead Candidate

The U.S.

Benzinga

Cannabis Reg. Update: California's Safe Drug Consumption Sites, FDA's Advisory Panel Discusses CBD In Food & More

FDA Advisory Panel To Discuss CBD Use In Food & Dietary Supplements The Science Board of the FDA is scheduled to meet on Tuesday, June 14, to discuss “challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”

Benzinga

FDA Accepts Myovant Sciences and Pfizer's Filing For Review In Uterine Fibroids

Myovant Sciences (NASDAQ: MYOV) and Pfizer (NASDAQ: PFE) received U.S.

Benzinga

Morning Brief: Top Financial Stories Dominating on Thursday, June 2

Reuters

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