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The Latest Breaking News from FDA

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

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

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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.

Benzinga

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.

Axios

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.

Benzinga

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

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

Axios

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

The Independent UK

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.

France 24

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.

Chicago Tribune

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.

Roll Call

America's FDA panel backs Moderna and Pfizer COVID-19 vaccines for children under five. Here's what that means

Advisors to US federal regulators are backing two COVID-19 vaccines for children as young as six months old, with the final decision to be watched closely by Australian health officials, along with parents eager to put pandemic concerns behind them.

ABC News

Moderna’s COVID shot for youngest children gets FDA panel’s support

Moderna Inc.’s COVID-19 vaccine for infants and toddlers won the support of a panel of U.S. regulatory advisers, putting parents one step closer to being able to protect their youngest against COVID-19 for the first time.

Tribune News Service

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Inverse

FDA just authorized Covid-19 vaccines for kids under 5. Here’s what parents need to know

An outside panel of experts for the FDA recommended both the Moderna and Pfizer vaccine for kids under 5. Shortly after, the FDA granted a EUA.

Axios

FDA committee recommends COVID shots for kids as young as 6 months

Children younger than 5 are the last group without access to the shots.

Benzinga

Why ACADIA Pharmaceuticals Shares Are Trading Higher Today?

Ahead of Acadia Pharmaceuticals Inc's (NASDAQ:ACAD) FDA AdComm meeting on Friday, the agency officials released their briefing documents, revealing a mixed bag of opinions. The company's resubmitted supplemental New Drug Application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP) has a target action date of August 4. Initially, the FDA…

The Independent UK

Fisher-Price issues warning after 13 infant deaths from rockers - what you need to know

No recall has been issued for the product, but parents are advised not to let newborns and toddlers sleep in the rockers

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Benzinga

55 Stocks Moving In Wednesday's Mid-Day Session

Gainers Sidus Space, Inc. (NASDAQ: SIDU) shares surged 92.4% to $2.77 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.

Benzinga

Why Kintara Therapeutics Shares Are Skyrocketing Today

Kintara Therapeutics Inc (NASDAQ: KTRA) shares are trading higher by 28.6% to $0.24 after the FDA granted Fast Track Designation to the company’s VAL-083.

The Independent UK

FDA advisers weigh COVID-19 shots for babies, young children

U.S. government advisers met Wednesday to decide whether to endorse COVID-19 shots for the youngest children, moving the nation closer to vaccinations for all ages

Benzinga

Kintara Therapeutics' Stock Shooting Higher As FDA Grants Fast Track Designation To Brain Cancer Drug

The United States Food and Drug Administration (FDA) has granted Fast Track Designation to Kintara Therapeutics’ (NASDAQ: KTRA) lead drug candidate VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM).

Benzinga

The Daily Biotech Pulse: FDA Committee Backs Moderna Shot For 5-17 Years, 180 Life Sciences Stock Plunges, Pfizer's Posts Disappointing Paxlovid Data

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

Benzinga

Why 180 Life Sciences Shares Are Plunging Today

180 Life Sciences Corp (NASDAQ:ATNF) received a written response from the U.K.'s regulatory agency and U.S. FDA related to questions submitted in a Type C meeting request for anti-TNF treatment, adalimumab, to treat early-stage Dupuytren's disease. Dupuytren's disease is a progressive fibrotic condition of the hand that causes the fingers to curl irreversibly…

Benzinga

Omega Therapeutics Submits IND For Liver Cancer Candidate

Omega Therapeutics, Inc. (NASDAQ: OMGA) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC).

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