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The Latest Breaking News from FDA

Recap Of Tuesday's Biotech Catalysts - End of The Day Summary

European Commission (EC) has approved AbbVie’s (NYSE:ABBV) lead asset RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis. AbbVie shares traded in a range of $150.33 to $153.56 on a day volume…

Benzinga

Some people with epilepsy find relief with CBD — but the market is murky

The federal government has legalized cannabidiol (CBD). The FDA also has approved one cannabis-derived prescription drug, Epidiolex, for three rare seizure conditions.

Inverse

Daily Biotech Pulse: EU Approval For AbbVie's Ulcerative Colitis Treatment, Angion Biomedica Evaluates Alternatives, Clinical Hold For Immuron's Bacterial Infection Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

Reformulated COVID vaccine boosters may be available earlier than expected

The Biden administration may scrap plans to expand eligibility for second boosters to younger adults. Instead, it's trying to speed up the next generation of boosters targeting the omicron variant.

WEKU

Parents become drug developers to save their children’s lives

Maggie Carmichael wasn’t developing like other kids. As a toddler, she wasn’t walking and had a limited vocabulary for her age.

Tribune News Service

Why Ketamine-Assisted Psychotherapy May Be The New Vanguard Of SUD Treatment

By Peter Loeb, CEO of Lionrock

Benzinga

My Baby Needed Special Formula From Europe. U.S. Trade Policy Made It Almost Unobtainable.

The FDA should not stand in the way of parents doing what’s best for their children.

Reason

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5 things to know about the FDA's flawed approach to accelerated drug approvals

An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.

WEKU

RLX Burns Down, But Not Out, With New Licensing Announcement

Key Takeaways: RLX has received a new manufacturing license as required under a new regulation announced earlier this year The license permits the company to produce rechargeable vaping devices at levels about 30% lower than its sales last year By Doug Young

Benzinga

Daily Biotech Pulse: KKR Invests In Medicine Start-Up, Revelation Bio Aces Allergic Rhinitis Study, Tonix Pharma Ends COVID-19 Antiviral Pact

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Does sun cream go out of date? Plus, the signs it has expired

We asked doctors and a pharmacist to tell us does sun cream go out of date, and how to tell if it has expired, to make sure you and your family are getting the best protection

GoodToKnow

Boost now or wait? Many wonder how best to ride out COVID's next wave

Gwyneth Paige didn’t want to get vaccinated against COVID-19 at first. With her health issues — hypertension, fibromyalgia, asthma — she wanted to see how other people fared after the shots. Then her mother got colon cancer.

Tribune News Service

How the pandemic set back drug safety

The best form of inspection is an unannounced one, but the pandemic changed the game for regulators. They’ll need to work together to protect consumers.

360info

Monkeypox has been declared a global emergency. Should you get a vaccine? And which one?

Should you get a monkeypox vaccine?

Miami Herald

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The Guardian - US

Critical elements of leading Alzheimer’s study possibly fraudulent

The highly influential paper, first published in 2006, has helped guide billions of dollars in US federal research into the disease

The Guardian - US

Paxlovid going underused due to doctors’ ‘misperceptions’, experts say

Clinicians are ‘skittish’ about the Covid antiviral, resulting in a failure to treat patients who could greatly benefit

Benzinga

Recap Of Friday's Biotech Catalysts - End Of The Day Summary

Bristol Myers Squibb (NYSE:BMY) received European Medicines Agency (EMA) Positive CHMP Opinion recommending approval for Opdualag (nivolumab and relatlimab) for treatment of patients with Unresectable or Metastatic Melanoma based on results from the Phase 2/3 RELATIVITY-047 trial. Bristol Myers shares traded in a range of $72.48 to $73.61 on a…

Inverse

Overturning Roe leaves people with autoimmune conditions in danger

People with inflammatory arthritis like rheumatoid arthritis are having trouble getting methotrexate in the wake of abortion bans.

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news in one place.

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WEKU

A Skittles lawsuit raises questions over titanium dioxide — a legal food additive

A suit has been filed against the maker of Skittles over titanium dioxide, a color additive that has been on the market for decades but which has been banned in food by European authorities.

Benzinga

CBD: New Study Finds Wide Evidence Of Mislabeling For Cannabidiol Products

In a new study, Johns Hopkins Medicine researchers tested more than a hundred topical cannabidiol (CBD) products, that are available online and at retail stores and found "significant evidence of inaccurate and mi

WEKU

Drugmakers are slow to prove medicines that got a fast track to market really work

Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.

Reason

January 6 Committee Wraps Summer Hearings With Footage of Hawley Fleeing, Detailed Account of Trump's Day

Plus: Electoral count reform, freeing baby formula from useless regulation, and more...

Reason

Review: The FDA's Awful Labeling Regulations Made the Baby Formula Shortage Worse

Elaborate labeling requirements blocked the importation of direly needed European baby formula.

Reason

A Quick Breakdown Of The Right To Contraception Act

In the wake of Dobbs, the Democratic-controlled House is passing a flurry of bills to "codify" constitutional rights that are not really in jeopardy. Yesterday, I wrote about the Respect For Marriage Act, which would require a state to recognize same-sex marriages performed in another state. This bill passed with…

Tribune News Service

House approves measure to protect the right to contraception

WASHINGTON — The House on Thursday passed legislation that would codify the federal right to contraception, although the measure faces slim odds in the Senate because of GOP concerns about the broadness of the bill.

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