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The Latest Breaking News from FDA

BioXcel Stock Surges 19% In After-Hours Trading: What You Need To Know

BioXcel Therapeutics Inc. (NASDAQ:BTAI) experienced significant after-hours momentum, jumping 19.09% to $6.24 in the after-hours trading session on Tuesday, as investors got ready for the release of important clinical trial results.

Benzinga

A new strain of Covid is causing a spike in California as officials grapple with Trump’s vaccine policies

Health officials under Robert F. Kennedy Jr. have delayed and gummed up the approval of new Covid-19 jabs even as the new ‘Stratus’ subvariant surges in the Golden State

The Independent UK

Gyre Therapeutics Gains Attention As Under-The-Radar Liver Fibrosis Drug Maker

The global biopharmaceutical landscape is rapidly evolving, driven by innovations targeting complex diseases like organ fibrosis and liver conditions. As companies push the boundaries of medical science, new therapies are emerging that promise to transform patient care and redefine market leadership in these critical areas.

Benzinga

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Argenx Immune Disorder Drug's Reach Could Get Much Bigger With Major Trial Win

Argenx SE (NASDAQ:ARGX) stock is trading higher on continued upward momentum after the company released topline data on Monday from the pivotal Phase 3 ADAPT SERON study of Vyvgart (IV: efgartigimod alfa-fcab).

Benzinga

8 Fast-Food Ingredients That Have Quietly Been Pulled in Multiple States

The fast-food industry is under immense pressure from consumers to offer “cleaner” and healthier menu options. In response, many of the largest chains have been quietly reformulating their recipes to remove controversial and artificial ingredients. These changes often happen without a major national press announcement. The companies will simply pull…

Grocery Coupon Guide

Why Are Food Recalls Reported Late in Certain Southern States?

When a food product is recalled for a safety issue like Listeria or E. coli, a rapid and effective communication system is critical to protecting public health. Federal agencies like the FDA and the USDA will issue a national alert, but it is often up to state and local health…

Grocery Coupon Guide

More than 20,000 cans of 7Up recalled over sugar label error

The sodas were distributed across several states and contain ‘full sugar’ says the FDA report

The Independent UK

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EXCLUSIVE: Virax Biolabs Inks Research Pact To Advance Long COVID Diagnostic Studies

Virax Biolabs Group Limited (NASDAQ:VRAX) announced on Tuesday that it had signed a Research Services Agreement (RSA) with Emory University's Center for the Advancement of Diagnostics for a Just Society (ADJUST Center) to conduct clinical studies of ViraxImmune.

Benzinga

7 Bills That Could Plummet by Next Year Under President Trump

Some financial experts remain optimistic that the administration's policies can help reduce other costs. So, will Trump lower bills?

GOBankingRates

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

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

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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).

The Independent UK

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.

Benzinga

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.

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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).

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…

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