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The Latest Breaking News from FDA

Is This the Supreme Court's Next Big Abortion Case?

Plus: An impressive book by a Supreme Court justice.

Reason

Why Serina Therapeutics Shares Are Trading Higher By Over 25%; Here Are 20 Stocks Moving Premarket

Shares of Serina Therapeutics Inc (NYSE:SER) rose sharply in pre-market trading after the company announced the FDA has provided written feedback supporting the advancement of SER-252.

Benzinga

3 Biotech Catalysts Present Major Opportunity

Three promising biotech names stand out for potentially catalyzing drugs currently on the market or in development; here's why they may rally further.

MarketBeat

From analysis to the latest developments in health,
read the most diverse news in one place.

Friday Plans Reviews (2025): Should You Get Friday Plans? An Honest Look at Friday Plans Pills

To satisfy a growing number of reader questions about the service, this article delves into Friday Plans reviews, the ordering process, and the safety standards behind Friday Plans pills.

Medical Daily

Tharimmune (THAR) Stock Is Surging Monday: What's Going On?

Shares of Tharimmune Inc (NASDAQ:THAR) are surging in Monday afternoon trading, continuing a rally that began last week. The stock’s rise comes in the absence of any company-specific news for the session, but follows last week’s announcement of promising simulation results for its lead clinical asset, TH104.

Benzinga

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

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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

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

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

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Roll Call

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.

Grocery Coupon Guide

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…

The Independent UK

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

Hormone therapy has been shrouded in confusion for years

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news in one place.

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The Mary Sue

‘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…

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?

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.

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