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The Latest Breaking News from FDA

COVID-19 vaccines for kids are mired in uncertainty amid conflicting federal guidance

It’s August, and parents and caregivers are frantically preparing their kids for a new school year by buying supplies, filling out forms and meeting teachers. This year, many parents also face a question that’s more complicated than usual: Should my child get an updated COVID-19 vaccine, and will I even…

The Conversation

Cognition Therapeutics Surges 30% Pre-Market After FDA Backs Phase 3 Trial Design For Alzheimer's Drug

Cognition Therapeutics Inc. (NASDAQ:CGTX) shares jumped 30% to $1.43 in pre-market trading on Wednesday after the company announced FDA confirmation of its Phase 3 trial design for Alzheimer’s drug Zervimesine (CT1812).

Benzinga

Brutal 2025 for Sarepta—Analysts Still Call for 179% Upside

Per two Wall Street analysts, one of 2025's biggest losers could be set up for a stunning recovery. They see over 175% upside in Sarepta Therapeutics.

MarketBeat

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Why Is Liquidia Stock Trading Higher On Tuesday?

Liquidia Corporation (NASDAQ:LQDA) reported on Tuesday a second-quarter loss of 49 cents, missing the consensus of a loss of 43 cents.

Benzinga

FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease

The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated’s (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

Benzinga

CDC Shooting Linked To Suspect's COVID-19 Vaccine Beliefs, Former Staff Blame RFK Jr. Hostility Toward Agency

A group of former U.S. Centers for Disease Control and Prevention (CDC) employees are blaming HHS Secretary Robert F. Kennedy Jr. for vilifying the agency’s workforce through “his continuous lies about science and vaccine safety, which have fueled a climate of hostility and mistrust."

Benzinga

Amphastar Secures FDA Nod For Iron Sucrose Injection, Analysts Eye Major Sales Momentum

On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s (NASDAQ:AMPH) Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

Benzinga

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Hims & Hers Remains Outside Novo Nordisk's Growing Legal Storm For Now

Hims Hers Health Inc. (NYSE:HIMS) has been one of 2025’s hottest telehealth stocks, nearly doubling in value year to date, but a deepening clash with Novo Nordisk A/S (NYSE:NVO) over compounded weight-loss drugs, and shifting FDA rules, has turned momentum into headwinds, sending shares sliding 10% in the past three…

Benzinga

7 Times Pet Food Was Recalled Without National Coverage

When a major pet food recall happens, it often makes national news, sending worried pet owners rushing to check their pantries. However, many smaller recalls issued by the U.S. Food and Drug Administration (FDA) never make the headlines. These quiet recalls can involve products contaminated with dangerous bacteria like Salmonella…

Grocery Coupon Guide

Tonix Pharmaceuticals (TNXP) Stock Surges On Q2 Earnings Beat And Upcoming FDA Catalyst

Shares of Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) are trading sharply higher Tuesday morning following the release of the company’s second-quarter financial results and operational update.

Benzinga

Altimmune Q2 FY2025 Earnings Call Transcript

Altimmune, Inc. (NASDAQ:ALT) reported its second-quarter financial results before Tuesday’s opening bell.

Benzinga

Sugar cookies sold at Target in 20 states recalled over fears of wood chip contamination

More than 800 cases of the sugar cookies were recently recalled

The Independent UK

5 Health Food Trends That Quietly Lost FDA Backing

For years, certain “health food” products have been promoted as miracle solutions for weight loss, better digestion, and overall wellness. Shoppers stocked their pantries with these items, trusting bold packaging claims and viral endorsements. But behind the scenes, the FDA has quietly shifted its stance on some of these trends—removing…

Grocery Coupon Guide

FDA May Not Renew Pfizer's Authorization For Covid Shots In Younger Children, Moderna Prepares To Boost Supply

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Benzinga

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The Independent UK

Ousted FDA vaccine chief Vinay Prasad is returning to the agency

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top vaccine regulator

Barchart

Profits May Be Just Around the Corner for This Strong-Buy Pharma Stock

Alnylam Pharmaceuticals (ALNY) shows strong price momentum, hitting new all-time highs on Aug. 11. ALNY has a 100% technical “Buy” opinion via Barchart. The company boasts a robust pipeline, recent FDA approvals, and dramatic projected revenue and earnings growth for 2025. Analyst sentiment is mostly bullish with high price targets....

Benzinga

IO Biotech's Combo Therapy For Skin Cancer Falls Just Short, Eyes FDA Talks Later This Year

IO Biotech (NASDAQ:IOBT) on Monday released topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted).

Benzinga

WeightWatchers Sees Revenue Boost From Semaglutide Prescriptions Despite Subscriber Drop

WW International, Inc. or WeightWatchers (NASDAQ:WW) stock surged Monday after it reported second-quarter 2025 combined revenues of $189 million, down 6% from the prior year. Growth in Clinical subscriptions offset declines in the Behavioral segment.

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Benzinga

Vinay Prasad's Comeback To FDA Sparks Debate Over Regulatory Direction

In a stunning reversal, Dr. Vinay Prasad is returning to his role as director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), just days after his resignation.

Kids Ain't Cheap

Image source: 123rf.com

Benzinga

Former Surgeon General Slams RFK Jr. Over mRNA Cuts, Says US 'Conceding To China,' 2 Million Lives At Risk

Former U.S. Surgeon General Jerome Adams is warning that halting federal funding for mRNA vaccine research will cost lives, derail medical breakthroughs, and hand a critical technological advantage to China.

The Independent UK

Warnings spread on TikTok about ‘Feel Free’ drinks that contain kratom, which has opioid-like effects

The FDA has recommended action to control certain kratom products, which are sold legally

Grocery Coupon Guide

10 Foods That Were Pulled for Containing Undeclared Allergens

Food recalls happen more often than you might think. One of the most common reasons? Undeclared allergens. This means a food contains something like peanuts, milk, or soy, but the label doesn’t say so. For people with allergies, this isn’t just a small mistake. It can be dangerous, even life-threatening.…

The Guardian - AU

Trump news at a glance: Lutnick threatens Harvard patents; former Fox commentator bound for UN

Commerce secretary begins process could let the government seize Harvard patents; Tammy Bruce nominated for deputy US ambassador to UN – key US politics stories from 9 August 2025

The Guardian - US

Vinay Prasad returns to FDA days after leaving under pressure from Laura Loomer

Prasad left the agency after far-right influencer released edited audio misleadingly suggesting he was anti-Trump

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