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The Latest Breaking News from the US Food and Drug Administration

Concord Biotech shares gain 6% after USFDA approval for Tofacitinib tablets

Concord Biotech's shares surged over 6% after receiving USFDA approval for its Tofacitinib Tablets in 5 mg and 10 mg strengths. This approval for rheumatoid arthritis and other conditions is expected to bolster its U.S. market presence and product portfolio, targeting a $500 million market opportunity.

The Economic Times

Concord Biotech shares jump 8% on USFDA nod for Mycophenolate Mofetil oral suspension

Concord Biotech shares saw a significant jump on Wednesday. This surge followed the company's announcement of receiving approval from the USFDA for its Mycophenolate Mofetil for Oral Suspension. This antimetabolite immunosuppressant is used in organ transplant patients.

The Economic Times

Kroger Cheese Garlic Croutons Recall: FDA Warns Product Tied to Toxic Milk Powder

Kroger Cheese Garlic Croutons have been recalled across several US states over a salmonella risk linked to milk powder in their seasoning, with no illnesses reported but specific batches withdrawn.

International Business Times UK

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Abortion Pills Can No Longer Be Sent by Mail as US Court Ruling Reinforces In-Person Pick-Up Only

A US federal appeals court has ruled against mail-order abortion pills, reinstating the requirement for in-person collection.

International Business Times

Abortion Pills Can No Longer Be Sent by Mail as US Court Ruling Reinforces In-Person Pick-Up Only

A US federal appeals court has ruled against mail-order abortion pills, reinstating the requirement for in-person collection.

International Business Times UK

FDA Warnings About Compounded Topical Finasteride and What Men Should Know

Hair loss sparks billion-dollar industries, endless internet debates, and a steady stream of miracle promises. Right in the middle of that noisy marketplace sits a medication that doctors have prescribed for decades: Finasteride. Recently, however, a growing trend has pushed this familiar drug into new territory. Instead of taking a…

Clever Dude

Olympic ski jumpers are rumored to have injected hyaluronic acid into their penises. What are the health risks?

As rumors swirl amid ‘Penisgate,’ the International Ski and Snowboard Federation says there’s no evidence to back up claims

The Independent UK

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Tomato soup sold in 14 states under recall over allergy concerns

The product was recalled after a routine inspection, which found that consumption could cause a serious allergic reaction

The Independent UK

Throw Away Your Old Pots NOW — FDA Issues Chilling Lead Warning Over Dozens of Imported Cooking Pans

The FDA has urgently warned Americans to discard 19 types of imported cookware after tests showed they may leach dangerous levels of lead into food.

International Business Times UK

Milk recalled due to potential contamination with cleaning agents

320 gallons of the fat-free milk were affected by the recall

The Independent UK

Babies who drank ByHeart formula got sick months before botulism outbreak, parents say

At least five families say their babies were treated for infant botulism after consuming ByHeart formula months before a current outbreak was detected

The Independent UK

What to know about a baby formula recall that has left at least 15 babies sick

The FDA is investigating 84 cases of infant botulism detected since August

The Independent UK

Gilead Reaches Settlement To Block Biktarvy Generics Until 2036

Gilead Sciences, Inc. (NASDAQ:GILD) on Monday entered into settlement agreements to resolve the patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration to market generic versions of Biktarvy.

Benzinga

Mountain Dew, Gatorade and Cheetos to undergo makeover amid health fears

PepsiCo is looking at purple sweet potatoes and carrots to color drinks like Mountain Dew and Cherry 7Up

The Independent UK

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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

Tonix Pharma's Drug Gets FDA Nod For Chronic Pain Condition, First New Therapy In Over 15 Years

On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s (NASDAQ:TNXP) Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults.

Benzinga

Novartis' Investigational Drug Aces Two Pivotal Trials For Chronic Disease Impacting Tears, Saliva

Novartis AG (NYSE:NVS) on Monday released topline data from two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, evaluating ianalumab (VAY736) in adults with active Sjögren’s disease.

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.

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Clever Dude

8 Personal Care Products That Are Banned in Other Countries

Personal care products are part of daily life. You use them to clean, moisturize, and protect your body. But not every product on store shelves is safe everywhere. Some countries have banned certain personal care products because of health risks. These bans might surprise you, especially if you use these…

The Conversation

No clear answers on antidepressants in pregnancy

The US Food and Drug Administration recently convened a panel of experts to examine a sensitive and increasingly urgent question: should antidepressants be prescribed to women suffering from depression during pregnancy?

The Independent UK

Married couple whose home was bursting with truckloads of illegal sex pills sentenced

Eduard Yusupov and Diana Fuzailov sold sexual enhancement products online via their company Love Potion, Inc., claiming them to be made from natural ingredients

Benzinga

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…

Reason

3-Parent Babies Born Healthy in the U.K.

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

International Business Times

US Authorizes Juul To Market Vaping Products

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

Benzinga

Why Is Milestone Pharmaceuticals Stock Plunging On Friday?

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) moved closer to potential FDA approval for its Cardamyst (etripamil) nasal spray, an investigational therapy for paroxysmal supraventricular tachycardia (PSVT), as the U.S. Food and Drug Administration (FDA) accepted the company’s response to prior issues.

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