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The Latest Breaking News from FDA

Brainstorm Cell Therapeutics Crashes 42% After Voluntary Nasdaq Delisting Announcement

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares crashed 42.74% to $0.67 in after-hours trading on Friday after the company announced its voluntary delisting from the Nasdaq Capital Market.

Benzinga

Thailand cracks down on ‘zombie pods’ drug

Thai authorities are tightening restrictions on the drug etomidate to curb its use in potentially deadly vape products known as “zombie pods”.

Bangkok Post

FDA authorizes Juul to continue selling e-cigarettes

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The Independent UK

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Florida supreme court upholds congressional map that weakens Black voters’ influence

Ruling is a win for Republicans, who anticipate losing US House seats in next year’s midterm elections

The Guardian - US

3-Parent Babies Born Healthy in the U.K.

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

Reason

US Authorizes Juul To Market Vaping Products

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

International Business Times

Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves

The FDA ruled that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching to vapes from cigarettes

The Independent UK

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Sarepta Therapeutics' Reorganization Boosts Investor Confidence

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) stock is trading higher on Thursday after the company issued an after-hours update on ongoing label expansion efforts for Elevidys, its approved gene therapy for Duchenne muscular dystrophy.

Benzinga

Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

Federal health officials will allow Juul to keep selling its electronic cigarettes

The Independent UK

Popular deodorant recall affects over 67,000 cases sold at Walmart, Amazon, and Dollar Tree

The deodorant was available at Walmart for $21 for a pack of three

The Independent UK

FDA Lifts Pause On Kezar's Liver Drug Trial—Next Stop Lupus Study

The Division of Hepatology and Nutrition of the U.S. Food and Drug Administration lifted the partial clinical hold on Kezar Life Sciences Inc.‘s (NASDAQ:KZR) completed PORTOLA Phase 2a trial evaluating zetomipzomib in autoimmune hepatitis (AIH).

Benzinga

Big Bucks For Better Barks: Gallant Lands $18M To Bring Game-Changing Stem Cell Therapies To Pets

San Diego biotech startup Gallant just raised $18 million in a Series B financing round, furthering its quest to deliver the first ready-to-use stem cell therapy through conditional U.S. Food and Drug Administration approval. But the company isn't directing those funds toward the treatment of sick humans. Rather, it's wants…

Benzinga

Tempus AI Stock Is Rising Wednesday: What's Happening?

Tempus AI Inc (NASDAQ:TEM) shares are trading higher Wednesday after the company announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ejection fraction software.

Benzinga

Trump administration is pushing for psychedelic therapy. Will it help or hamper the field?

US health secretary Robert F Kennedy Jr said he wants psychedelic therapies approved within a year, surprising even the staunchest supporters of the drugs.

Euronews

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The Independent UK

Will RFK Jr.'s push for psychedelic therapy help or hamper the emerging field?

Health Secretary Robert F

Reason

Fourth Circuit Rejects Claim that West Virginia Abortion Law Is Preempted

A mifepristone manufacturer is unsuccessful in evading West Virginia's prohibition on abortion, even when performed by medication.

Benzinga

GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc’s (NYSE:GSK) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk.

Benzinga

RFK Jr. Says Ice Cream Makers Must Ditch Synthetic Dyes By 2028—What It Means For Major Brands

The U.S. Health Secretary Robert F. Kennedy Jr.‘s announcement that ice cream makers will eliminate synthetic dyes in their formulations could impact the listed ice cream makers who would be required to execute the change.

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The Independent UK

More elderly Americans are choking to death. Are these devices the answer?

Each year, choking claims the lives of more than 4,100 Americans who are 65 or older

Benzinga

Zimmer Biomet To Lead Orthopedic Robotics With Monogram's AI Tech

Zimmer Biomet Holdings, Inc. (NYSE:ZBH) on Monday agreed to acquire Monogram Technologies Inc. (NASDAQ:MGRM) for an upfront payment of $4.04 per share, corresponding to an equity value of approximately $177 million and an enterprise value of approximately $168 million.

Barchart

ProKidney Just Set a New 52-Week High. Should You Buy, Sell, or Hold PROK Stock Here?

As ProKidney hits a fresh 52-week high, can it sustain momentum through late-stage trials, or should investors stay cautious amid the market’s mixed view?

Everybody Loves Your Money

6 FDA Policies That Have Never Been Updated Since the ’70s

The Food and Drug Administration has long stood as one of the most influential regulators in the United States, wielding enormous power over what people eat, drink, and use for medicine. Yet beneath the surface of modern scientific breakthroughs and ever-evolving technology lies a startling reality: some of the policies…

Benzinga

AstraZeneca's Drug Shows Promise For Resistant Hypertension In Phase 3 Trial

AstraZeneca Plc (NASDAQ:AZN) on Monday released topline data from the BaxHTN Phase 3 trial of baxdrostat in patients with uncontrolled or treatment-resistant hypertension.

Reason

America's Baby Formula Rules Are Due for an Update

A new effort called Operation Stork Speed aims to fix outdated FDA rules that block alternative baby formulas from reaching U.S. shelves.

The Guardian - US

‘Tremendous uncertainty’ for cancer research as US officials target mRNA vaccines

Amid Trump cuts and state-level backlash, experts worry that progress in messenger RNA vaccines could stall

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