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The Latest Breaking News from FDA

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

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

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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

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

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Benzinga

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

The Independent UK

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....

Barchart

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.

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.

Benzinga

7 Popular Lunch Snacks That Were Quietly Recalled

Image source: 123rf.com

Kids Ain't Cheap

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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

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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

Bored Panda

Kim Kardashian Travels To Mexico For Procedure Unavailable In US, Shares Surgery Room Pics

“Wow, the privilege to fly on your personal plane to Mexico. Not everybody can do that."

Grocery Coupon Guide

9 Foods Rebranded After Contamination—But Still on Shelves

Food recalls make headlines, but what happens after the news fades? Many products linked to contamination get pulled, rebranded, and quietly return to store shelves. This matters because you might be buying these foods without knowing their history. Food safety is a real concern, and rebranding can hide past problems.…

The Guardian - US

Pfizer Covid vaccine for young children may not be renewed by FDA

Email obtained by Guardian says Pfizer was told approval may not be granted, meaning Moderna may have to fill gap

Grocery Coupon Guide

9 Personal Care Items Pulled From Shelves Overseas But Not in the U.S.

Have you ever wondered why some personal care items are pulled from shelves in Europe or Asia—but still casually stocked here in the U.S.? The difference often comes down to regulation and consumer safety standards. While your local store carries a familiar product, it might contain ingredients that other countries…

The Independent UK

The affected ice cream was sold across three states

Benzinga

Genmab/AbbVie Partnered Blood Cancer Combination Drug Cuts Risk Of Disease Progression By 79%

Genmab A/S (NASDAQ:GMAB) released results Thursday of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

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