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The Latest Breaking News from FDA

FDA Approves Eli Lilly's Drug For Advanced Breast Cancer

On Thursday, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Co.’s (NYSE: LLY) Inluriyo (imlunestrant) for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

Benzinga

Could Harrow's New Sedation Pill Change Millions Of Medical Procedures Forever?

Harrow, Inc. (NASDAQ: HROW), a U.S.-based provider of ophthalmic disease management solutions, announced on Friday that it has agreed to acquire Melt Pharmaceuticals, Inc., a clinical-stage company developing non-opioid, non-IV sedation therapies for hospitals and outpatient care.

Benzinga

RFK Jr. sets off new abortion alarms with latest move

The Trump administration is facing conflicting political pressures over Kennedy's recent move.

Axios

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Biogen Faces FDA Setback On High-Dose Nusinersen Filing For Spinal Muscular Atrophy

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Biogen Inc.’s (NASDAQ: BIIB) supplemental New Drug Application (sNDA) for the high-dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA).

Benzinga

Why Capricor Therapeutics Stock Is Surging Today

Shares of Capricor Therapeutics Inc. (NASDAQ: CAPR) are up Thursday after the company announced progress regarding one of its rare disease therapeutics. The biotech company’s stock jumped 18% immediately following the news.

Benzinga

Surprising Foods to Enjoy and Avoid to Live Longer

Want to live a longer, healthier life? Here are some surprising foods to enjoy (coffee!) and to avoid (some types of spinach!).

Kiplinger

RFK Jr. launches FDA review of pill used in two-thirds of abortions

Medication abortions have become vital for some patients in states with abortion bans

The Independent UK

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Harmony Biosciences' Genetic Disorder Drug Disappoints In Phase 3 Study

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) released topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS).

Benzinga

First Successful Gene Therapy for Huntington's Disease Slows Disease Progression by 75%

In a landmark clinical trial, uniQure's gene therapy AMT-130 slowed Huntington's disease progression by 75% over 3 years. The one-time treatment may mark the first disease-modifying therapy for this incurable neurodegenerative condition.

Medical Daily

Trump's touting of an unproven autism drug surprised many, including the doctor who proposed it

A Trump administration decision to repurpose an old chemotherapy drug for autism has surprised many experts — including the physician who recently proposed the idea

The Independent UK

Tylenol maker prepares for glut of lawsuits after Trump’s baseless warnings

‘Don’t take Tylenol,’ President Donald Trump repeatedly warned on Monday

The Independent UK

Atai Life Sciences Experimental Depression Drug Shows Sustained Benefit In Treatment-Resistant Patients

Atai Life Sciences (NASDAQ:ATAI) and Beckley Psytech Limited, a private clinical-stage biopharmaceutical company, released data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin benzoate) in patients with treatment-resistant depression (TRD).

Benzinga

HIMS Stock Just Got Rocked (Again) By the FDA. This Analyst Still Thinks Hims & Hers Can Surge 50%.

Despite a sharp selloff after the latest FDA warning, Hims & Hers continues to post triple-digit annual gains and strong revenue growth, with at least one analyst projecting a 50% upside.

Barchart

Is Tylenol the same as paracetamol, and should you take it in pregnancy? Here’s why experts say Trump should be ignored

The US president claims the painkiller also known as acetaminophen is linked to autism. Here’s what the science says

The Guardian - UK

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Benzinga

ARS Pharma Urges FDA To Delay Approval Of Aquestive's Allergic Reaction Treatment

ARS Pharmaceuticals Inc. (NASDAQ:SPRY) filed a petition Monday urging the FDA to delay approval of Aquestive Therapeutics Inc.'s (NASDAQ:AQST) experimental epinephrine treatment, citing safety, dosing, and real-world use concerns.

Evening Standard

Fact-checking Trump's paracetamol and autism announcement

President Donald Trump made several claims during his conference to announce a ‘link’ between Tylenol and autism - but how much is true?

Benzinga

What's Going On With Kenvue Stock Tuesday?

Kenvue Inc. (NYSE:KVUE) shares are trading higher Tuesday despite President Donald Trump saying the Food and Drug Administration will notify physicians that use of acetaminophen or Tylenol during pregnancy could be associated with increase risk of autism.

Benzinga

Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection

The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s (NASDAQ:SRRK) apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).

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Grocery Coupon Guide

The 7 Dirtiest Secrets of the Food Industry

The modern food industry is a miracle of science and logistics. It is also an industry that is filled with several shocking and often unappetizing secrets. To produce the huge amount of cheap and consistent food that we demand, the industry relies on a variety of controversial practices and ingredients.…

The Independent UK

Trump’s inability to pronounce acetaminophen draws laughter from across the internet

‘If you can’t pronounce acetaminophen, you probably shouldn’t be giving out medical advice related to acetaminophen,’ one X user suggested

Barchart

2 ‘Strong Buy’ Stocks That Wall Street Believes Can Soar 360% to 780%

These two growth stocks are attractive for investors seeking big upside in exchange for higher risk.

Evening Standard

Donald Trump claims of paracetamol link to autism should be ignored, Wes Streeting says

Health Secretary says expectant mothers should listen to doctors over US president on medical matters

International Business Times UK

Trump Administration Backs Leucovorin for Autism — How It Works, the Science Behind It and Its Effectiveness

The Trump administration has backed the use of leucovorin, a folate-based drug, for autism treatment. Here's what the science says, how it works, and why experts are divided on its effectiveness.

International Business Times UK

Paracetamol, Autism and Panic: How to Read the Science Before You Change Your Pregnancy Plan

UK health bodies reaffirm paracetamol is safe in pregnancy after Trump autism claims. Experts warn misinformation could deter vital treatment.

International Business Times UK

White House Slammed for Tylenol-Autism Claim as Experts Insist 'It's the Vaccines' Driving Autism Fears

Experts blast Trump's Tylenol-autism claims, stressing vaccines are safe and misinformation, not paracetamol, drives autism anxiety.

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