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The Latest Breaking News from FDA

A new regime: On the Emergency Use Authorisation regime in India and clinical trials

Mistrust, arbitrary decree and lax regulations have historically plagued clinical trials in India

The Hindu

Does Medicare cover Ozempic, Wegovy, and other drugs taken for weight loss?

Medicare isn’t allowed to cover drugs taken for weight loss because the 20-year-old Medicare Modernization Act specifically excludes them.

Fortune

Pineapple in frozen fruit potentially exposed to Listeria, prompting wide recall

Sunrise Growers Inc. has issued a voluntary recall of certain frozen fruit products due to potential Listeria contamination.

LiveScience

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Up First: Titan implosion; 1 year after Roe; Evan Gershkovich's appeal rejected

All five people aboard the Titan are believed dead after an implosion. Saturday marks a year since the Supreme Court overturned Roe. The FDA approves the first gene therapy for muscular dystrophy.

WEKU

Explained | What is lab-grown meat and what did the U.S. recently approve?

“Cell-cultivated chicken” – that’s the official name of chicken meat that is grown in a laboratory for human consumption. On June 21, two California-based companies were cleared to make and sell cell-cultivated chicken in the country in what is being hailed by stakeholders in the concept as a major step…

The Hindu

Biden order aims to protect, expand contraception access - Roll Call

Biden's third executive order responding to the Supreme Court's Dobbs decision is the first focused primarily on birth control.

Roll Call

FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the U.S.

The warning from the Food and Drug Administration is the latest attempt by regulators to crack down on illegal disposable vapes that have poured into U.S. stores in recent years.

WEKU

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We are closer than ever to being able to 3D print medicines. Here's why that's important

3D-printed medicine could be the future of personalised healthcare, with research now suggesting printed tablets have reached a sufficient quality to match the standards set for conventionally manufactured tablets.

The Conversation

First gene therapy for deadly form of muscular dystrophy gets FDA approval for young kids

The U.S. Food and Drug Administration has approved the first gene therapy to treat a deadly form of muscular dystrophy

The Independent UK

FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the US

U.S. regulators have sent warning letters to dozens of retailers selling fruity disposable e-cigarettes, including the current best-selling brand, Elf Bar

The Independent UK

Disposable vape sales soared after FDA focused efforts elsewhere

E-cigarette sales surged during the pandemic, a spike concentrated in disposable vapes after they took a back seat in federal enforcement.

Roll Call

GOP aims to use budget to limit abortion

On top of sweeping state abortion bans, the GOP has been pursuing less-publicized federal anti-abortion moves

Salon

‘As long as it tastes good’: People react to US approval to sell chicken cultivated by cells

Two California companies have received approval to sell cell-cultivated chicken

The Independent UK

US House Approves FDA Office In Abraham Accord Region To Reduce Dependence On Chinese Pharmaceuticals

Proposal gathers momentum amid improving relations between Israel and Arab countries, with bipartisan support in Congress.

Zenger

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LiveScience

1st over-the-counter gel for erectile dysfunction approved by the FDA

Unlike other erectile dysfunction treatments, Eroxon is a gel and doesn't require a doctor's prescription.

Tribune News Service

Sen. Schumer outlines steps to combat ‘dire’ drug shortage

Warning of a coming “panic” over decreasing drug supplies, Senate Majority Leader Chuck Schumer on Sunday outlined steps to strengthen the supply chain.

The Independent UK

Sue Gray ‘breached Whitehall impartiality rules’ over Labour chief of staff job talks

A Cabinet Office inquiry alleged the Partygate investigater could have been ‘suspended or sacked had she not quit’

Tribune News Service

COVID boosters should be updated to target XBB strain, US health advisers say

COVID-19 shots should be reformulated to target an XBB subvariant of the highly infectious omicron strain to provide the best protection during the U.S. fall and winter season, health regulators said.

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The Independent UK

Jennifer Aniston’s ‘go-to’ collagen supplement recalled

Aniston has been Chief Creative Officer of Vital Proteins since 2020

WEKU

Testosterone is probably safe for your heart. But it can't stop 'manopause'

A new study finds men with low T who used a gel to increase the hormone did not have a higher rate of heart attacks than men on a placebo. But the anti-aging benefits are iffy.

The Independent UK

Scientist behind Ozempic says drug can make life ‘so miserably boring’

Ozempic is a once-weekly semaglutide injection used for the treatment of type 2 diabetes

Woman & Home

Wegovy is "not a magic bullet" - 3 doctors reveal what you need to know as the drug is set to be prescribed in the UK

As Wegovy is set to be available on prescription in the UK, we asked doctors what they think of the controversial weight loss injections

Los Angeles Times

COVID vaccine should be updated to target XBB strain, FDA committee says

With an eye toward enhancing protection against the coronavirus, which is still evolving and circulating, federal health advisers said Thursday that the next round of COVID-19 vaccines should be updated to target the now-dominant XBB strains.

WEKU

FDA advisers back updated COVID shots for fall vaccinations

A panel of advisers to the Food and Drug Administration has recommended revising the current COVID-19 vaccine so that it specifically targets omicron.

The Independent UK

FDA advisers consider changing COVID vaccine to target latest omicron strain

The COVID-19 vaccines are on track for a big recipe change this fall

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