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The Latest Breaking News from FDA

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

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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

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.

Inverse

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.

Axios

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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…

Benzinga

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

The Independent UK

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.

Benzinga

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

The Independent UK

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

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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).

Benzinga

Morning Brief: Top Financial Stories Dominating on Wednesday, June 15

Reuters Warner Bros Discovery To Undergo Major Global Ad Sales Team Restructuring

Benzinga

Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

Pfizer Inc (NYSE:PFE) shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid (nirmatrelvir and ritonavir tablets) in patients at standard risk for developing severe COVID-19. In previously reported interim analyses, the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met. Non-significant 70% relative…

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Benzinga

FDA Committee Backs Moderna's COVID-19 Shot For Kids, Adolescents: Report

Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine received unanimous backing from the FDA's committee of independent immunization experts for children ages 6 through 17.

Benzinga

24 Stocks Moving in Wednesday's Pre-Market Session

Gainers Boxed, Inc. (NYSE: BOXD) rose 38.3% to $1.95 in pre-market trading. Boxed reported that Director Andrew Pearson bought 150,000 shares at an average price of $1.82 per share.

Benzinga

82 Biggest Movers From Yesterday

Gainers Comera Life Sciences Holdings, Inc. (NASDAQ: CMRA) gained 126.5% to settle at $2.65 on Tuesday.

Benzinga

Cannabis Reg. Update: FDA To Review CBD Again, DEA Wins In Hemp Extract Case & More

FDA To Review CBD Once Again The U.S. Food and Drug Administration’s Science Board is expected to review the idea of incorporating cannabinoids into dietary supplements on Tuesday at the public advisory committee meeting.

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

Benzinga

Benchmark Downgrades AeroClean After Share Price Rallies

Benchmark analyst Robert Wasserman downgraded AeroClean Technologies Inc (NASDAQ:AERC) to Hold from Buy, without a price target. The analyst notes that despite a poor overall market outlook, the company's shares have quickly reached and exceeded earlier price targets. Wasserman downgraded the rating on AERC at this time due to share price and market volatility.…

Benzinga

Here's How Citi Views Amylyx Pharma

Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) to $33 from $32, with a Buy rating. It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak) bodes well for ongoing FDA review. Availability in Canada and using ALSFRS-R data as the primary basis…

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