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The Latest Breaking News from FDA

FDA Flags Alarming Contamination At Novo Nordisk Indiana Plant, Including Cat Hair, Bacteria, And Foreign Particles

The U.S. Food and Drug Administration (FDA) has identified repeated quality control failures, including foreign particle contamination, inadequate investigations, and insufficient corrective actions at the Novo Nordisk A/S (NYSE:NVO) operated facility in Bloomington, Indiana.

Benzinga

BeOne Cashes In On Amgen's Cancer Drug Royalties In Multibillion-Dollar Pharma Tie-Up

BeOne Medicines Ltd. (NASDAQ:ONC) on Monday agreed to sell its royalty rights on the worldwide sales, excluding China, of Amgen Inc.’s (NASDAQ:AMGN) Imdelltra (tarlatamab-dlle) for up to $950 million to Royalty Pharma Inc. (NASDAQ:RPRX).

Benzinga

Ice Cream sold at Walmart and other stores in a dozen states is under recall for ‘life-threatening’ error

Blue Bell Ice Cream’s “Moo-llennium Crunch Ice Cream” has been recalled.

The Independent UK

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Keurig Dr Pepper, Valneva, Venu Holding And Other Big Stocks Moving Lower On Monday

U.S. stocks were mixed, with the Dow Jones index falling more than 200 points on Monday.

Benzinga

FDA Pushes Back Axogen Avance Nerve Graft Decision By 3 Months

The U.S. Food and Drug Administration (FDA) on Monday extended the Prescription Drug User Fee Act (PDUFA) goal date for Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application (BLA) for Avance Nerve Graft by three months to December 5.

Benzinga

Safety Concerns Hit Valneva As Ixchiq Chikungunya Virus Vaccine Is Suspended In US

Valneva SE (NASDAQ:VALN) stock is trading lower on Monday after the U.S. Food and Drug Administration (FDA) suspended the license for Ixchiq, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness.

Benzinga

What's Going On With Coya Therapeutics Stock?

Shares of Coya Therapeutics Inc (NASDAQ:COYA) are trading higher Monday morning after the company provided an update regarding the development of a new treatment for Amyotrophic Lateral Sclerosis (ALS).

Benzinga

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HCW Biologics' Shares Surge After Unveiling Next-Gen Cancer Immunotherapy Platform

HCW Biologics Inc. (NASDAQ:HCWB) stock is trading higher on Monday, with a session volume of 10.85 million compared to the average volume of 132.51K as per data from Benzinga Pro.

Benzinga

Argenx Targets FDA Label Expansion After Vyvgart Trial Success

Argenx SE (NASDAQ:ARGX) released topline data on Monday from the pivotal Phase 3 ADAPT SERON study of Vyvgart (IV: efgartigimod alfa-fcab).

Benzinga

Congress sees bipartisan bright spot in sunscreen legislation - Roll Call

Lawmakers are working on legislation to lower market barriers for new sunscreens, an effort to bring the U.S. in line with other countries.

Roll Call

11 Items Retailers Remove Before FDA Inspectors Arrive

Grocery store inspections are a routine part of keeping our food supply safe. When the FDA shows up, retailers want to present their best face and avoid costly violations. That’s why some items quietly disappear from shelves before inspectors walk in. Understanding what gets pulled can help shoppers make informed…

Grocery Coupon Guide

10 Everyday Products That Were Labeled “Misleading” by the FDA

Every time you shop, you trust that the products on the shelves are labeled honestly. Yet, even everyday items can carry claims that stretch the truth or mislead shoppers. The Food and Drug Administration (FDA) has flagged many popular products for labeling that could confuse or trick consumers. Understanding which…

Grocery Coupon Guide

Hot flashes? Night sweats? What to know about hormone therapy during menopause

Hormone therapy has been shrouded in confusion for years

The Independent UK

‘IM GONNA GET SUPERPOWERS!!!’: Woman buys Great Value bag of shrimp from Walmart. Then she realizes it’s ‘radioactive’

Something strange is going on at Walmart. Recently, TikTok user Fae (@starsquishya) bought a bag of Walmart’s Great Value bag of shrimp. But what was meant to be a tasty snack became something else entirely after the US Food and Drug Administration (FDA) issued a warning about the popular food…

The Mary Sue

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Benzinga

What's Going On With Takeda Stock On Friday?

On Friday, Takeda Pharmaceutical Co Ltd's (NYSE:TAK) stock wobbled after touching as low as $14.53 during the premarket session, before bouncing back to about $15.47 at last check Friday.

Benzinga

NBCUniversal, Netflix, ESPN Vie For Baseball Rights As Major League Baseball Seeks Bigger Revenues

Major League Baseball is in advanced talks with multiple media giants, including Comcast Corporation's (NASDAQ:CMCSA) NBCUniversal, Netflix Inc (NASDAQ:NFLX), and The Walt Disney Company's (NYSE:DIS) ESPN, on a series of new rights deals that could reshape how fans watch the sport.

Benzinga

Biohaven Advances Toward Potential First FDA-Approved Therapy For Spinocerebellar Ataxia, FDA Drops Advisory Meeting

Biohaven Ltd. (NYSE:BHVN) stock is trading higher on Friday following an update with respect to its New Drug Application for troriluzole for adult patients with Spinocerebellar Ataxia (SCA).

Barchart

Worried About a Market Crash? Here Are 3 Stocks That ‘Big Short’ Star Michael Burry Loves Here.

Here are three top stocks that the ‘Big Short’ star Michael Burry owns in Q2 of 2025. Are UNH, REGN, and LULU undervalued right now?

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Benzinga

Ionis Pharma Wins FDA Nod For First RNA-Targeted Therapy For Rare Genetic Swelling Disorder

On Thursday, the U.S. Food and Drug Administration (FDA) approved Ionis Pharmaceuticals, Inc.’s (NASDAQ:IONS) Dawnzera (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Benzinga

Achieve Life Sciences Inches Closer To FDA Nod For First New Quit-Smoking Drug In 20 Years

Achieve Life Sciences Inc. (NASDAQ:ACHV) is moving closer to a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades, positioning the company for a high-stakes commercial launch in 2026.

Grocery Coupon Guide

Why So Many Nutrition Panels Have Been Quietly Altered

If you have a keen eye, you may have noticed that the Nutrition Facts panel on your favorite packaged foods looks different from what it did a few years ago. These changes are not your imagination. Food manufacturers have been quietly altering their nutrition labels for a variety of reasons,…

Benzinga

Gildea's Kite Pharma Just Acquired Interius—$350 Million Move Shakes Up Cancer Therapy

As biotechnology companies increasingly seek innovative approaches to enhance cancer treatment, strategic acquisitions are becoming a key pathway for expanding capabilities and integrating advanced therapeutic platforms. Kite Pharma, a Gilead Sciences Inc. company (NASDAQ:GILD) on Thursday agreed to acquire Interius BioTherapeutics, a privately held biotechnology company developing in vivo CAR…

Benzinga

Top 3 Risk Off Stocks Which Could Rescue Your Portfolio This Month

The most oversold stocks in the consumer staples sector presents an opportunity to buy into undervalued companies.

Euronews

Walmart recalls frozen shrimp in the US over potential radioactive contamination

One food safety expert says the risk is low from the recalled shrimp, which was sold in 13 US states.

Benzinga

Lung Disease-Focused Insmed 'Must-Own' Name For Investors

William Blair initiated coverage on Insmed Incorporated (NASDAQ:INSM), citing that the clinical and commercial execution of its drugs can significantly increase Insmed's valuation.

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