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The Latest Breaking News from FDA

The Week Ahead In Biotech (May 1-7): Phathom FDA Decision, Pfizer, Vertex Pharma Lead Earnings News, Ophthalmology Conference Presentations, And More

Biotech stocks posted weekly declines yet again in the week ending April 29, taking cues from the weak broader market sentiment. Big pharma earnings, clinical readouts and pipeline updates moved stocks during the week.

Benzinga

Pressure builds for COVID vaccines approval for littlest kids

Moderna's request for approval of its COVID -19 vaccine in children under six years amps up pressure on the Food and Drug Administration to act quickly to approve the shots.

Axios

Editorial: The FDA rightly moves to extinguish menthol cigarettes

The Food and Drug Administration has proposed banning menthol-flavored cigarettes, potentially beginning in 2024. It’s a tragedy that it is taking this long, but it’s never too late to save a life — or in this case, potentially hundreds of thousands of lives.

Tribune News Service

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Radiofrequency spinal cord stimulation shows improved longer-lasting pain relief: Study

According to a new study, chronic pain spinal cord stimulation (SCS) uses an implanted device to supply a small amount of electricity directly to the spinal cord, altering or blocking nerve activity and minimizing the sensation of pain reaching the brain.

Dynamite News

QNRX: FDA Clearance To Move QRX003 Clinical Testing Forward; Positive Implications

By M. Marin NASDAQ:QNRX READ THE FULL QNRX RESEARCH REPORT

Benzinga

U.S. FDA Approves AbbVie's RINVOQ® (upadacitinib) for Ankylosing Spondylitis (AS)

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE: ABBV) RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) .

Benzinga

FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete. The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)…

Benzinga

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48 Stocks Moving In Friday's Mid-Day Session

Gainers Belite Bio Inc. ADR (NASDAQ: BLTE) shares surged 144.8% to $14.69. Belite Bio priced its 6 million ADS IPO at $6 per ADS.

Benzinga

FDA sets June meetings on COVID vaccines for youngest kids

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children

The Independent UK

Mid-Morning Market Update: Markets Down; Nasdaq Falls 100 Points

U.S. stocks traded lower this morning, with the Nasdaq Composite dropping around 100 points on Friday.

Benzinga

AOC Defends Due Process as Colleagues Greenlight Asset Seizure Bill

Plus: Homeland Security's new Disinformation Governance Board, the FDA's menthol ban, and more...

Reason

The Daily Biotech Pulse: FDA Approves Bristol Myers' Oral Heart Disease Drug, European Approval For Merck's Keytruda, Genocea Restructures, Zymeworks' Takeover Bid

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

Benzinga

74 Biggest Movers From Yesterday

Gainers T Stamp Inc. (NASDAQ: IDAI) shares surged 123.8% to close at $4.70 on Thursday. Trust Stamp reported the launch of its Biometric Multi-Factor Authentication (Biometric MFATM) solution.

Benzinga

U.S. FDA Approves Bristol Myers Squibb's Camzyos™ (mavacamten) for the Treatment of Adults With obstructive HCM

Bristol Myers Squibb (NYSE: BMY) announced the U.S.

Benzinga

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Salon

White House: Paxlovid shortage is over

As VP Harris takes Paxlovid after her COVID-19 diagnosis, the White House is making the drug easier to access

Benzinga

U.S. FDA removes Clinical Hold on Finch's investigational new drug (IND) application for CP101

The U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch Therapeutics Group (NASDAQ: FNCH) investigational new drug (IND) application for CP101 in the prevention of recurrent C. difficile infection (CDI).

Benzinga

Venus Concept Gets FDA 510(k) Clearance for Venus BlissMAX with expanded indication

Venus Concept Inc. (NASDAQ: VERO) received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Venus BlissMAX device with an expanded indication for use in new areas of the body and an increase in RF energy output.

Salon

120,000 pounds of ground beef recalled

Over 100,000 pounds of ground beef have been recalled over E. coli concerns

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Reason

The FDA's Menthol Cigarette Ban Is a 'Racial Justice' Issue, but Not in the Way Its Supporters Mean

The proposed rule, which targets the cigarettes that black smokers overwhelmingly prefer, will harm the community it is supposed to help.

Benzinga

Moderna Seeks FDA Emergency Use Nod For COVID-19 Shot In Kids 2-6 Years

Moderna Inc (NASDAQ: MRNA)

Tribune News Service

Herschel Walker spent years promoting health products with dubious claims

ATLANTA — Senate candidate Herschel Walker has spent years promoting and developing health-conscious products with dubious benefits and a skepticism from the medical community, a review by The Atlanta Journal-Constitution has found.

Benzinga

FDA Gives Green Signal To Pfizer's Duchenne Gene Therapy Trial

After the FDA lifted its hold on a late-stage study, Pfizer Inc (NYSE:PFE) said it would open the first U.S. trial sites for its experimental gene therapy for a muscle-wasting disorder. The FDA had put Pfizer's Investigational New Drug (IND) application for fordadistrogene movaparvovec on hold, and Pfizer has addressed the agency's requests related…

Benzinga

Details Of Revive Therapeutics' Update On Bucillamine Phase 3 Trial For COVID Treatment

Revive Therapeutics (OTC: RVVTF) has provided an update on Phase 3 of its Buc

Tribune News Service

FDA proposes ban on menthol cigarettes, flavored cigars

WASHINGTON — The Food and Drug Administration on Thursday proposed a long-awaited ban on menthol cigarettes and flavored cigars, targeting products used by more than a third of smokers.

Axios

FDA proposes ban on menthol cigarettes

FDA commissioner Robert Califf said these rules "are appropriate for the protection of public health."

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