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The Latest Breaking News from FDA

Mid-Day Market Update: Nasdaq Down 1%; Icosavax Shares Plummet

U.S. stocks pared gains midway through trading, with the Nasdaq Composite dropping 1% on Friday.

Benzinga

36 Stocks Moving In Friday's Mid-Day Session

Gainers Forge Global Holdings, Inc. (NYSE: FRGE) shares jumped 66.4% to $20.70.

Benzinga

EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc (NYSE: MRK) for

Benzinga

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U.S. Senate Green-Lights Bipartisan Marijuana Research Bill Ahead Of House Legalization Vote

On Thursday, the Senate gave a green light to a bipartisan marijuana bill meant to promote marijuana research, reported Marijuana Moment.

Benzinga

Why Cutera's Shares Are Soaring Today

The FDA has granted 510(k) clearance to Cutera Inc's (NASDAQ:CUTR) AviClear for acne. The Company notes that AviClear is the first and only energy-based device to receive this designation to treat mild, moderate, and severe acne. AviClear is a laser treatment that offers a safe, prescription-free solution for acne. In addition to reducing existing acne,…

Benzinga

FDA Pushes Bristol Myers' Reblozyl Decision Date In Non-Transfusion Dependent Beta Thalassemia

The

Benzinga

Drugs that treat opioid use disorder are a good use for multibillion-dollar settlement funds

States, cities, counties and tribal governments across the nation will soon receive a windfall through several major opioid settlements. Drug distributors and manufacturers, including Purdue Pharma and the Sackler family members who own it, will relinquish a total of about US$32 billion for their role in the overdose crisis. Other…

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The Daily Biotech Pulse: MEI Pharma Wilts On Adverse Regulatory Development, Decision Day For Zogenix, AN2 Therapeutics IPO

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

Benzinga

34 Stocks Moving in Friday's Pre-Market Session

Gainers Clever Leaves Holdings Inc. (NASDAQ: CLVR) rose 40.5% to $2.22 in pre-market trading after the company reported better-than-expected Q4 sales results and reaffirmed FY22 guidance.

Benzinga

Why MEI Pharma Stock Is Plummeting After Hours

MEI Pharma Inc (NASDAQ: MEIP) shares are plunging in Thursday's after-hours session after the company provided an investor update following a recent meeting with the U.S. Food and Drug Administration.

Benzinga

Google Submits Fitbit's Passive Heart Rate Monitoring Feature For FDA Approval

Alphabet Inc (NASDAQ: GOOG) has submitted data to the FDA

Benzinga

Hawaii Passes And Amends Two Measures To Form Psilocybin Working Group, Move Research Forward

In Hawaii, senators approved two identical measures to form a psilocybin working group, Marijuana Moment reported. The goal of the group would be to explore the therapeutic potential of the psychedelic, but the resolutions were amended and patient access will be contingent on federal approval of psilocybin. Both proposals —sponsored by…

Benzinga

Five Companies Developing Second Generation Psychedelics For Mental Health

Along with the psychedelic renaissance came a new type of drug: second generation psychedelics. Developed from classic psychedelics molecules, these upgraded compounds could offer improved therapeutic profiles with reduced side effects. For some companies in the psychedelics space, second generation psychedelics could be the key to success in an increasingly…

Benzinga

How Rivals Merck, Bristol Myers Benefit From Eli Lilly's FDA Snag

The Food and Drug Administration on Thursday rejected a lung cancer drug Eli Lilly tested only in China, but LLY stock inched higher.

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Benzinga

FDA Rejects Lilly's Sintilimab/Chemo Combo Therapy In First-Line Lung Cancer Setting

The

The Independent UK

FDA reviews ALS drug after lobbying by patients, politicians

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

The Independent UK

FDA advisory panel to discuss additional Covid-19 boosters: What we know so far

Pfizer and Moderna seek approval for second ‘booster’ doses as White House warns US has exhausted funding to buy more shots

Benzinga

Pfizer's RSV Vaccine Candidate Receives FDA Breakthrough Therapy Tag For Prevention of RSV In Older Adults

The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's (NYSE:PFE) respiratory syncytial virus (RSV) vaccine candidate (PF-06928316 or RSVpreF) to prevent lower respiratory tract disease caused by RSV in 60 years of age or older. The positive results primarily inform the FDA decision of Phase 2a study evaluating the safety, immunogenicity, and efficacy…

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Benzinga

FDA Approves Novartis' Pluvicto As First Targeted Radioligand Therapy For Prostate Cancer

The FDA approved Novartis AG's (NYSE:NVS) Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat patients with a type of advanced prostate cancer that has spread to other parts of the body. Pluvicto is a targeted radioligand therapy for adult patients who have already undergone other anticancer treatments. The company said it had submitted…

Benzinga

Quest Diagnostics Secures CDC Contract To Support COVID-19 Research

The Centers for Disease Control and Prevention (CDC) has granted a contract to Quest Diagnostics Inc (NYSE:DGX) to perform testing and provide laboratory data analysis to help identify patterns in SARS-COV-2 seroprevalence on a multistate basis. Quest was awarded the contract following a competitive bid. The total contract value with all options is valued…

Benzinga

Celcuity Plans To Start Pivotal Gedatolisib Trial In Breast Cancer In 1H 2022

Celcuity Inc (NASDAQ:CELC) concluded two formal meetings with the FDA to obtain their feedback on the gedatolisib Phase 3 trial in the breast cancer setting. The study dubbed VIKTORIA-1 will evaluate gedatolisib combined with fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer. The trial will include adult patients whose disease has…

Benzinga

The Daily Biotech Pulse: Novartis Prostate Cancer Drug Lands FDA Approval, Ligand Announces SPAC Deal To Spin Off Antibody Business, Lilly's Lung Cancer Therapy Hit With CRL

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

Asharq Al-Awsat

Moderna Says Infant Covid Vaccine Succeeded in Trial

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response. Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated…

Benzinga

Biden Administration Contemplating Second COVID-19 Booster Shot Recommendation Within Weeks: Politico

The Biden administration could authorize a fourth dose or second COVID-19 booster shot for people aged 65 years and above within weeks, amid rising concern over a potential resurgence of cases,

Benzinga

DFFN: Additional Tissue Oxygenation Trial Results Expected Mid-2022…

By David Bautz, PhD NASDAQ:DFFN READ THE FULL DFFN RESEARCH REPORT

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