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The Latest Breaking News from FDA

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 · Jun 15, 2022

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 · Jun 15, 2022

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 · Jun 15, 2022

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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 · Jun 15, 2022

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 · Jun 15, 2022

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 · Jun 15, 2022

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

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

Benzinga · Jun 15, 2022

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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 · Jun 15, 2022

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 · Jun 15, 2022

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 · Jun 15, 2022

82 Biggest Movers From Yesterday

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

Benzinga · Jun 15, 2022

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.

Benzinga · Jun 15, 2022

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 · Jun 14, 2022

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 · Jun 14, 2022

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Benzinga · Jun 14, 2022

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…

Benzinga · Jun 14, 2022

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 · Jun 14, 2022

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 · Jun 14, 2022

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

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Benzinga · Jun 14, 2022

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 · Jun 14, 2022

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 · Jun 14, 2022

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

CNBC

Benzinga · Jun 14, 2022

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…

Tribune News Service · Jun 14, 2022

Editorial: Needed action on menthol cigarette ban

Three generations of LaTrisha Vetaw's family have smoked menthol cigarettes. It might even be four, since Vetaw knows that her great-grandfather smoked but isn't sure what brand he lit up.

Benzinga · Jun 14, 2022

Lilly-Incyte Snag FDA Nod For Patchy Hair Loss Treatment — Smaller Rival's Stock Shoots Up In Sympathy

Alopecia areata, an autoimmune disorder that causes patchy hair loss, now has a new treatment that has been approved by the Food and Drug Administration.

Los Angeles Times · Jun 14, 2022

Editorial: The FDA is right to ban menthol cigarettes

Take a deep breath, America. We’ve made serious progress against cigarette smoking. According to the U.S. Centers for Disease Control and Prevention, 23% of adults were smokers in 2000. By 2020, the rate had fallen to 12.5%. Teen use of traditional cigarettes has plummeted from 22.5% in 2002 to 6%…

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