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The Latest Breaking News from FDA

‘Anti-expert crusade’: what Trump’s hollowing out of US health institutions means for Australia

The impact of Robert F Kennedy Jr on US health organisations will affect research funding and access to medicines but may force Australia to step up, say experts

The Guardian - AU

What is cesium 137? FDA detects radioactive contamination in second product

Federal regulators have detected possible radioactive contamination in spices exported from Indonesia

The Independent UK

What is leucovorin, the drug the FDA approved to treat autism?

This week the FDA approved the generic drug as a treatment for autism – a move that shocked health experts

The Guardian - US

From analysis to the latest developments in health,
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Pfizer Faces Court Over Depo-Provera Brain Tumor Claims

Pfizer Inc. (NYSE: PFE) faces mounting legal challenges over claims that its contraceptive injection Depo-Provera (DMPA) is linked to brain tumors, with a key court hearing set for late September that could determine whether affected women can pursue their cases in court.

Benzinga

Sanofi Expands Insulin Savings Program To Cover All US Patients

The U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Sanofi SA’s (NASDAQ: SNY) Genzyme Corporation.

Benzinga

FDA Approves Crinetics Pharma's First Daily Pill For Rare Growth Disorder

On Thursday, the U.S. Food and Drug Administration (FDA) approved Crinetics Pharmaceuticals, Inc.’s (NASDAQ: CRNX) Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

Benzinga

Why Is Organogenesis Stock Trading Lower Friday?

Organogenesis Holdings Inc. (NASDAQ: ORGO) shared topline data on Thursday from the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA).

Benzinga

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FDA Expands Use Of Regeneron's Evkeeza To Infants With Rare Cholesterol Disorder

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals, Inc.’s (NASDAQ: REGN) Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).

Benzinga

Crinetics Pharmaceuticals, BlackBerry, Perpetua Resources And Other Big Stocks Moving Higher On Friday

U.S. stocks were higher, with the Dow Jones index gaining more than 200 points on Friday.

Benzinga

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

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

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Kiplinger

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!).

The Independent UK

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

Benzinga

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).

Medical Daily

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.

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news in one place.

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The Independent UK

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

Benzinga

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).

Barchart

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.

The Guardian - UK

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

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?

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