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FDA General

Left ventricular assist device (HeartMate 3) over a computer rendering of the device attached to a heart above FDA APPROVED

LVAD Approved for Children

FDA clears the way for HeartMate 3 use in younger population

COVID-19 UPDATE and Other News over a background of illustrated coronaviruses

'We Want Them Infected'; Extra Vax Doses; Tom Cruise, Distancing Enforcer

A daily roundup of news on COVID-19 and the rest of medicine

sacubitril/valsartan (ENTRESTO) over a computer rendering of a heart above FDA ADCOMM

FDA Panel Backs Entresto, Spironolactone for Broader HF Use

But committee stops short of advocating categorical approval for HFpEF

Bridge-EnhancedACL Repair (BEAR) Implant over a computer rendering of the implant above FDA APPROVED

FDA OK's First-Ever Synthetic Implant for ACL Tears

Bioresorbable device fills gap between torn ligament ends

Sacubitril/Valsartan (Entresto) over a computer rendering of the cardiovascular system above FDA ADCOMM.

FDA Review Gives Rosy Outlook for What Could Be First HFpEF Drugs

Advisory committee weigh unusual moves for Entresto and spironolactone

Liraglutide (Saxenda) over a photo of an overweight teen male above FDA APPROVED

Saxenda OK'd for Teens with Obesity

Liraglutide label now includes adolescents as young as 12

Gallium 68PSMA-11 (Ga 68 PSMA-11) over a computer rendering of prostate cancer above FDA APPROVED

FDA OKs 'Game Changer' Radiotracer for Prostate Cancer

PET imaging drug detected metastasis at initial diagnosis, outperformed standard for PSA recurrence

A bottle of Colchicine capsules in front of a vortex of $100 bills

Colchicine Approval Took a Huge Toll on CMS

As centuries-old drug is explored for COVID-19, study details the price of approval

baricitinib (Olumiant) + remdesivir (Veklury) over a nurse pushing an elderly patient鈥檚 hospital bed above FDA APPROVED

FDA OKs JAK Inhibitor and Remdesivir Combo for Severe COVID-19

EUA first for drug that acts on inflammation pathway, agency says

AHA over a computer rendering of a human heart

Omega-3s Humbled by Corn Oil Placebo in Two Trials

Implications for REDUCE-IT's icosapent ethyl unclear

AHA over a computer rendering of a human heart

Omecamtiv's Benefit in HFrEF Trial Gets Lukewarm Reception

Can novel oral drug stand out from the crowd?

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Doc Convicted for Needless Surgeries; COVID Test Racket; Biden's FDA Chief

The past week in healthcare investigations

VisAbility Micro Insert over a photo of the device above FDA ADCOMM

Presbyopia Device Fails to Win Over FDA Panel

Data suggest modest benefit and risk for scleral implant system

Ticagrelor (Brilinta) over a computer rendering of a brain with a flash of light symbolizing a stroke above FDA APPROVED

Brilinta Wins Indication in Recurrent Stroke Prevention

FDA approval based on THALES give the drug a foothold beyond CVD

NSAIDs over a pregnant woman holding a white tablet and glass of water above FDA WARNING

FDA Warns Against NSAIDs in Pregnancy After 20 Weeks

Risk of kidney complications and low amniotic fluids may jeopardize fetus

A man holding the dropper of a bottle labeled CBD DROPS

Reddit Users Self-Medicating With CBD for Treatable Conditions

Patients may be substituting cannabis compound for evidence-based care

ALKS 3831 (olanzapine/samidorphan) over a photo of a man looking cheerful and looking anguished above FDA ADCOMM

FDA Panel: Some Risk OK for Olanzapine Combo With Less Weight Gain

11-6 majority said labeling was sufficient to mitigate dangers from opioid antagonist component

AR19 over a photo of a male child with a white pill on his tongue above FDA ADCOMM

FDA Panel: All Thumbs Down for Amphetamine Product Meant to Deter Abuse

Unanimous vote that risks outweigh benefits

A screenshot of a Benadryl-themed TikTok filmed by a female teen

Teen's Death Prompts Warning on 'Benadryl Challenge'

FDA tries to squelch latest stupid craze

A mature woman uses a pulse oximeter at home

How Accurate Are Home Blood Oxygen Monitors?

The Skeptical Cardiologist examines pulse oximeters labeled not for medical use

A pile of Belviq and Belviq bottle labels

A Closer Look at FDA Decision to Pull Lorcaserin

More cancers, multiple primaries, and deaths in CAMELLIA-TIMI 61 influenced agency decision

Reformulated OxyContin over a photo of an OxyContin branded oxycodone tablet above FDA ADCOMM

Did Reformulated OxyContin Really Discourage Abuse?

FDA advisors to review Purdue Pharma's flagship product, redesigned in 2010 to resist snorting and injection

A red magic marker draws an X over a black box warning

FDA Drops Boxed Warning From Invokana Label

Amputation risk "lower than previously described"

belantamab mafodotin (Blenrep) over a micrograph of multiple myeloma above FDA APPROVED

FDA OKs Anti-BCMA Drug for Multiple Myeloma

Accelerated approval for belantamab mafodotin after four other therapies

atezolizumab (Tecentriq) over a photo of advanced melanoma above FDA APPROVED

Triplet OK'd as First-Line Therapy in Melanoma

Immunotherapy plus targeted combo nets FDA approval in BRAF-mutant population

Photo of the Essure device between a womans thumb and forefinger

Essure Linked to Higher Rates of Abnormal Uterine Bleeding and Chronic Pain

Early results of a post-market analysis show adverse effects after years of FDA action

The IQOS smokeless cigarette and charger

Heat-Not-Burn Cigarettes Win Coveted Marketing Claims

FDA allows Marlboro Heatstick labels to boast "reduced exposure" though not "reduced risk"

FDA Slaps Stem Cell Firm Linked to Nebraska Infections

EUCYT Laboratories also pushing exosome treatments for COVID-19

A blue-gloved hand holds a box of Hydroxychloroquine tablets

HCQ No Longer Approved Even a Little for COVID-19

Study after study showed no benefit, and now the FDA has had enough

inebilizumab (Uplizna) over a computer rendering of the eye, optic nerve, and brain above FDA APPROVED

New NMO Drug Gets FDA Nod

B-cell depleting inebilizumab is the second neuromyelitis optica spectrum disorder treatment approved

An advertisement showing a woman holding a smart phone and using the carafem app to schedule an abortion.

Telemedicine Abortion Gains Momentum During Pandemic

But FDA regulations on mifepristone still limit access

METFORMIN over a photo of a glucose meter and test strips above FDA RECALL

NDMA Prompts Metformin Recall

FDA finds certain products with excessive levels of potential carcinogen

Flortaucipir F18(Tauvid) over a series of CT brain scans above FDA APPROVED

Alzheimer鈥檚 Tau Tracer Wins Landmark Approval

"Major advance" toward diagnosing Alzheimer's with brain imaging

Cancer cells with OncoBreak in the center.

End of Life and COVID-19; DCIS Doubles Cancer Risk; Training for 'Bad News'

News, features, and commentary about cancer-related issues

A close up of a Juicy Juice Fruit Punch label

Is There Really Fruit Juice in That 'Juice' Drink?

Labels often exaggerate

A hand holding a COVID-19 antibody quick test

Push Needed for At-Home Coronavirus Antibody Testing

An opportunity for the U.S. to catch up

SOLD OUT over a bottle of Midazolam

COVID-19 Puts ICU Sedatives Into Shortage

Manufacturers caught short by soaring demand

A close up of a chloroquine tablet in a package

Chloroquine Is Not a Harmless Panacea for COVID-19

There's a real safety concern with malaria drug

The packaging of Singulair

Montelukast Warning Upgraded

Existing risk information not prominent enough and needs a black box, FDA decides

The Spravato nasal spray applicator

Spravato Debate Still Rages

Journal airs questions about efficacy data, potential for harm

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