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The Latest Breaking News from FDA

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

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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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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…

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

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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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Benzinga

Approval Of Baricitinib For Patchy Baldness Validates Clinical Patch For This Small-Cap Stock

Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, was developed by Incyte Corp (NASDAQ:INCY) and launched in collaboration with Eli Lilly And Co (NYSE:LLY), received FDA approval for hair loss disorder known as alopecia areata (AA). Olumiant was first approved for the treatment of rheumatoid arthritis (RA) in 2018. The above nod is expected to…

Benzinga

Moderna's COVID-19 Shot Likely Related To Higher Heart Inflammation Risk Than Pfizer's: Reuters

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine may relate to a higher risk of heart inflammation in some age groups than Pfizer Inc (NYSE:PFE) - BioNTech SE's (NASDAQ:BNTX) shot, Reuters reported citing the Centers for Disease Control and Prevention. Citing recent data, CDC said that the findings on myocarditis and pericarditis, types of heart inflammation linked to both the…

The Independent UK

FDA advisers consider Moderna's COVID shots for older kids

A government advisory panel is meeting to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens

Benzinga

FDA OKs Apple Watch To Help Monitor Symptoms Of Parkinson's Disease

A San Francisco-based software company received permission from the U.S. Food and Drug Administration to use Apple Inc. (NASDAQ: AAPL) wearable technology to track Parkinson's symptoms.

Benzinga

The Daily Biotech Pulse: FDA Nod For Lilly-Incyte's Patchy Hair Loss Treatment, First Regulatory Submission For EQRx, Soleno's Promising Data From Prader-Willi Candidate

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

Benzinga

Morning Brief: Top Financial Stories Dominating on Tuesday, June 14

CNBC

Benzinga

Why Outset Medical Shares Are Trading Lower Today

Outset Medical Inc (NASDAQ:OM) implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA review and clearance of a 510(k). The company submitted for changes made since the device's original March 2020 clearance. Outset has not identified any safety issues with Tablo. It will continue…

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