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The Latest Breaking News from FDA

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

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

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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

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

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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

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

Health Secretary Robert F

The Independent UK

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.

Reason

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.

Benzinga

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

The Independent UK

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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.

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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

Benzinga

Medtronic Stock Is Climbing Friday: What's Going On?

On Wednesday, the Centers for Medicare Medicaid Services (CMS) proposed a significant step toward broader adoption of renal denervation (RDN) by offering coverage for both radiofrequency (rfRDN) and ultrasound (uRDN) technologies for uncontrolled hypertension. This coverage would be granted under a Coverage with Evidence Development (CED) framework, requiring treatment within…

Benzinga

Why Is Milestone Pharmaceuticals Stock Plunging On Friday?

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) moved closer to potential FDA approval for its Cardamyst (etripamil) nasal spray, an investigational therapy for paroxysmal supraventricular tachycardia (PSVT), as the U.S. Food and Drug Administration (FDA) accepted the company’s response to prior issues.

The Independent UK

Bread sold at Kroger and Walmart in a dozen states is under recall for ‘life-threatening’ problem

Hartford Bakery recalled its Lewis Bake Shop Artisan Style half-loaf bread after a packaging error led to undeclared hazelnuts in some loaves.

Benzinga

Capricor's Lead Duchenne Therapy Hits FDA Regulatory Roadblock

Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is trading lower on Friday.

Benzinga

FDA Grants Complete Approval To Moderna's COVID-19 Vaccine For Children As Young As 6 Months

The U.S. Food and Drug Administration (FDA) has approved Moderna Inc.’s (NASDAQ:MRNA) supplemental Biologics License Application (sBLA) for Spikevax, the company’s COVID-19 vaccine, in children six months through 11 years of age who are at increased risk for COVID-19 disease.

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