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The Latest Breaking News from FDA

Rhythm Pharmaceuticals' Shares Dive Following FDA's Verdict On IMCIVREE Drug

The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS).

Benzinga

Pfizer and Moderna COVID-19 vaccines are on the verge of approval for US kids under five. When could it happen in Australia?

After US regulators took a major step towards approving COVID-19 vaccines for kids under five, here's what you need to know about the possibility of something similar happening in Australia.

ABC News

Key US baby formula plant closes again as ‘torrential storms’ cause flooding

Production halt at Abbott Laboratories in Michigan will probably extend shortages for ‘a few weeks’

The Guardian - US

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HC Wainwright Sees Opportunity For Acadia's Alzheimer's Candidate

HC Wainwright says FDA's briefing document on ACADIA Pharmaceuticals Inc's (NASDAQ: ACAD) pimavanserin was not unexpected.

Benzinga

Baby formula company stops production again due to storms

It is unclear when the facility will restart production

The Independent UK

Walgreens to launch business that will connect customers with clinical trials

Some Walgreens customers might soon get a new kind of message from the company, asking if they’d like to participate in a clinical trial.

Chicago Tribune

Abbott again halting baby formula production at its Michigan facility after flooding

Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.

Chicago Tribune

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Walgreens Launches Clinical Trial Business

Walgreens Boots Alliance Inc (NASDAQ:WBA) has launched its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreens will combine the flexible clinical trial model with its vast data on patient insights, partner-enabled health and technology capabilities, and in-person and virtual care options. The…

Benzinga

White House Consults with Law Professors in Anticipation of Dobbs Ruling (Updated)

The Biden Administration is apparently considering a range of responses should te Supreme Court overturn Roe v. Wade.

Reason

Abbott's baby formula plant closes again after severe storms and flooding

Abbott's Sturgis, Mich., plant was open for less than two weeks before it had to close again after flooding from severe weather. The company said it hopes to resume production in a few weeks.

WEKU

The best time to make a major life decision, according to science

In this edition of Inverse Daily, read about the tarantula nebula, making decisions using science, and more.

Inverse

Baby formula production at Michigan plant delayed by severe flooding

Barely two weeks after production restarted at a Michigan plant that supplies baby formula, flooding in the area has shut down the work as supply continues to dry up nationwide.

Tribune News Service

Senseonics' Next-Gen Eversense E3 Glucose Monitoring System Scores European Approval

Senseonics Holdings Inc (NYSE:SENS) has received CE Mark approval for the next-generation Eversense E3 CGM System. Senseonics' European commercial partner, Ascensia Diabetes Care, will make the improved System, which can be used for up to 6 months, available from Q3 of 2022. The next-generation System offers improved accuracy with the longest-lasting sensor available,…

Benzinga

Checkpoint' Cancer Therapy Shows Almost 55% Response Rate In Skin Cancer Patients

Checkpoint Therapeutics Inc (NASDAQ:CKPT) announced positive interim efficacy results from its registration-enabling trial of cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The design of the interim analysis incorporated recent FDA feedback and is intended to support the approval of cosibelimab…

Benzinga

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Benzinga

Johnson & Johnson Urges FDA To Take Interim Steps As It Continues To Review CBD

The FDA's Science Board has once again reviewed the idea of incorporating cannabinoids into dietary supplements.

Benzinga

More Trouble For Baby Formula Production As Thunderstorms, Flood, Hit Abbott's Troubled Michigan Plant

Just a few weeks after reopening its baby formula Sturgis, Michigan plant, Abbott Laboratories (NYSE:ABT) said it paused EleCare specialty baby formula production after recent thunderstorms flooded part of the facility. The company has informed the FDA and will conduct comprehensive testing with an independent third party to ensure the plant is safe to…

Benzinga

Aquestive Therapeutics Reveals Favorable Data From Epinephrine Trial For Allergies

Aquestive Therapeutics Inc (NASDAQ:AQST) announced topline results from the first three arms of Part 3 of the EPIPHAST study for its AQST-109 epinephrine oral film for allergic reactions, including anaphylaxis. In the first three arms of Part 3, AQST-109 12 mg continued to show rapid absorption with favorable pharmacokinetics. The median time to…

Benzinga

Moderna Plans COVID-19 Vaccine Trial For Infants: WSJ

Moderna Inc (NASDAQ: MRNA) is reportedly planning to evaluate its COVID-19 vaccine in infants aged three months to 6 months.

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Axios

A major pandemic hurdle is being crossed with young kids getting vaccine access

Parents of infants and toddlers are a major step closer to having front-line protection against COVID after a key FDA committee on Wednesday unanimously recommended authorizing vaccines for kids as young as six months.

Benzinga

71 Biggest Movers From Yesterday

Gainers Sidus Space, Inc. (NASDAQ: SIDU) shares jumped 225% to close at $4.68 on Wednesday after the company announced it is part of Collins Aerospace team which was awarded NASA's Exploration Extravehicular Activity services contract with a potential value of $3.5 billion.

Axios

Abbott halts production at Michigan baby formula plant after storm causes flooding

The beleagured Sturgis plant only resumed production less than 2 weeks ago.

The Independent UK

AP under fire for using photos of children in pain to report on youth vaccine approval

Children under the age of five still can’t get vaccinated yet in US

France 24

US FDA panel backs first Covid-19 jabs for children under five

The first COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday.

Chicago Tribune

FDA panel recommends COVID vaccines for little kids, but questions remain about where they’ll be available

CHICAGO — Mary MacMillan is eager to get her 2-year-old son vaccinated against COVID-19, once vaccines are authorized for young kids. But she has a lot of questions about how to get the shots.

Roll Call

FDA panel gives green light to pediatric COVID-19 vaccines - Roll Call

Those under 5 are the last group eligible for the Moderna and Pfizer vaccines, and shots could go out as soon as next week.

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