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FDA General

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

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

Lorcaserin (BELVIQ) over a photo of a man measuring his large belly above FDA RECALL

Diet Drug Yanked Over Cancer Risk

Patients should stop taking lorcaserin

A female child holds a peanut in her hand and points a finger at it

Will Palforzia Revolutionize Peanut Allergy Tx?

FDA approves first-ever peanut immunotherapy, but wide adoption uncertain

Illustration of numerous women holding their stomachs in distress

Women Burned by Quick Fix for Heavy Periods

For many, 5-minute fix is anything but

Illustration of numerous women holding their stomachs in distress

How We Used FDA MAUDE Data on NovaSure

Attuned to limitations, investigative team used conservative approach

SOLD OUT over a vial of Heparin

How to Handle a Heparin Shortage: Effective Strategies

With supply chain issues in China, it's a real threat, group says

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

Meet the 'Lien Doctors'; Hidden Clinical Trial Data; Google Nabs More Medical Records

This past week in healthcare investigations

A computer rendering of a cell releasing exosomes

Serious Illnesses in Nebraska Tied to Exosome Therapy

New trend in unapproved stem cell therapy led to sepsis in some patients

A Vivitrol advertisement

FDA Warns Alkermes on Vivitrol Ads

Campaign omits important risk information, agency says

An advertisement of LIVEYON PREMIERMAXCB

FDA Warns Liveyon Over Cord Blood Stem Cell Products

Company slapped for distributing unapproved products, deviating from quality manufacturing practices

A screenshot of a Google search showing Piracetam for sale in various markets

European 'Brain-Boosting' Drug Pushed as Supplement in U.S.

Study finds FDA-rejected supplement can deliver doses high above EU-approved range

A computer rendering of the Watchman left atrial appendage (LAA) occlusion device being implanted

Watchman: Sicker Patients, More Deaths Than in Trials

Medicare data paint a different picture of the LAA occluder

A photo of Mila and Julia Vitarello

Mila's N-of-1 Trial Detailed in NEJM

Neurologic scores stabilized, seizures diminished with tailored antisense oligonucleotide therapy

A bottle of generic Zantac (Ranitidine) tablets

Does Zantac Break Down Into a Carcinogen?

Rather than contamination, "the fundamental problem is that it's an unstable molecule"

TCT over a photo of the Moscone Center, San Francisco, CA

Mitral Valve Procedure Learning Curve Raises Access Question

And guess which procedures are next for public outcome reporting...

semaglutide (Rybelsus) over a photo of pills and a glucose monitor above FDA APPROVED

Oral GLP-1 Drug Wins FDA Nod

First oral agent in class to be approved

ESC over a photo of the city of Paris.

Risk-Based Thresholds for hs-Troponin I Safely Speed MI Rule-Out

HISTORIC suggests benefit to patients, clinicians

Should the Elderly Discontinue Statins?

The debate goes on, but Kevin Campbell, MD, believes every patient is different

The Cuban flag hanging across a street in Havana.

Want a Glimpse of Single-Payer Healthcare? Look at Cuba

The distinction between single-payer and universal care is critical, says Niran S. Al-Agba, MD

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