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The Latest Breaking News from FDA

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

From analysis to the latest developments in health,
read the most diverse news in one place.

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

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

Salon

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.

Benzinga

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120,000 pounds of ground beef recalled

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

Salon

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.

Reason

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

Moderna Inc (NASDAQ: MRNA)

Benzinga

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.

Tribune News Service

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

Benzinga

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.

Tribune News Service

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Axios

FDA proposes ban on menthol cigarettes

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

Benzinga

Baxter's FDA Review For Novum IQ Large Volume Pump Put On Hold, Lowers FY22 EPS Outlook

Baxter International Inc (NYSE:BAX) has posted Q1 revenue of $3.71 billion, beating the consensus of $3.68 billion, up 26% on a reported basis, 29% on a constant currency basis, and 3% on an operational basis. Adjusted EPS of $0.93 increased 22%, ahead of the consensus of $0.80. Baxter's newly acquired Hillrom businesses…

The Independent UK

Moderna seeks FDA approval of Covid vaccine for children aged six months to five years old

The request arrives one month after the drug company said its two-dose jabs provided immune protection in youngest children

The Independent UK

FDA to issue plan banning menthol in cigarettes, cigars

The U.S. government is set to release its long-awaited plan to ban menthol cigarettes and flavored cigars

Get all your
news in one place.

100’s of premium titles.
One news app.

Benzinga

Could Biden Extinguish Tobacco Stocks With This Regulation?

The U.S. government could be speeding up a plan to ban menthol cigarettes, according to a new report. Here’s the new timeline and two stocks that could be affected.

Benzinga

TransMedics Receives FDA Premarket Approval for OCS™ DCD Heart Indication

TransMedics Group, Inc. (NASDAQ: TMDX) received premarket approval (PMA) from U.S. Food and Drug Administration (FDA) for its OCS™ Heart System in favour of use with organs from donors after circulatory death (DCD).

Tribune News Service

Moderna applies for US clearance of COVID shot for young kids

Moderna Inc. applied for emergency use authorization for its COVID-19 vaccine in children from six months to under 6 years old after a successful trial showed two doses generate high levels of antibodies to the virus.

Benzinga

The Daily Biotech Pulse: Moderna Seeks FDA Approval For COVID-19 Shot For Children 2-6, Tax Disclosure For Amgen, Fast Track Tags For SQZ Biotech, Timber Pharma Candidates

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

Benzinga

Timber Pharmaceutical Gets FDA Fast Track designation for TMB-001 in Severe Subtypes of Congenital Ichthyosis

Timber Pharmaceuticals, Inc. (NYSE: TMBR) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TMB-001 for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).

Roll Call

FDA proposes ban on menthol cigarettes, flavored cigars - Roll Call

The FDA Thursday proposed a ban on menthol cigarettes and all flavored cigars, a move that could take effect in about a year.

The Independent UK

Moderna seeks to be 1st with COVID shots for littlest kids

Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children

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