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An image of of package of Xeljanz

FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risks

Use for inflammatory conditions limited to those who fail on TNF blockers

FDA WARNING Eco-Med Ultrasound Gels and Lotions over a photo of a bottle of EcoGel 200 ultrasound gel.

FDA Warns on Contamination Risk With Eco-Med Ultrasound Gels

Healthcare providers must toss all of company's gels and lotions, agency says

FDA APPROVED over a computer rendering of a tumor.

FDA Grants Tissue-Agnostic Approval to Dostarlimab for dMMR Tumors

Overall response rate of 41.6% in various tumor types with mismatch repair deficiency

FDA APPROVED calcium, magnesium, potassium, and sodium oxybates (Xywav) over a photo of a young woman asleep at her computer.

First Drug OK'd for Idiopathic Hypersomnia

Sleep drug Xywav gains a new indication

HIMSS over a conceptual image of a physician accessing data via a tablet.

Notice Any Rule Changes in Washington? You Can Thank COVID

"It's opened a Pandora's box, which is not going back"

A map of the world created by the arrangement of various pills and capsules.

CMS Proposes to Rescind 'Most Favored Nation' Drug Pricing Rule

Regulation from Trump administration had been barred from taking effect due to court challenges

A Juul vape pen and packaging and pack of Virginia tobacco flavored pods.

All Eyes on FDA: The Upcoming Regulation of Juul E-Cigarettes

Will the public health be protected?

FDA ADCOMM TriGuard 3 cerebral protection device over a computer rendering of the device.

TAVR Debris Deflector Doesn't Fly With FDA Advisory Panel

TriGuard 3 met with skepticism in its bid for approval

FDA APPROVED casirivimab and imdevimab (REGEN-COV) over a computer rendering of COVID-19 viruses in aerosol & a masked person

Monoclonal Antibody Cocktail Authorized for Post-COVID Exposure

REGEN-COV becomes first monoclonal antibody treatment with EUA following exposure alone

A computer rendering of t-cells attacking a COVID-19 virus.

Call in the T-Cell Cavalry to Fight COVID in the Immunocompromised

Preliminary research suggests immunotherapy could play role in protecting vaccine non-responders

An x-ray image of a senior woman with a left ventricular assist device implanted

More Medical Device Deaths Than We Previously Thought?

Study finds many reports of patient deaths that were not classified as a death in FDA database

Photo of vials of the drug Shingrix.

Shingrix OK'd for Immunocompromised Adults

CDC's vaccine committee currently discussing vaccine for this population, manufacturer says

FDA APPROVED immunoglobulins (IVIG; Octagam 10%) over photos of adults with dermatomyositis

FDA Approves IVIG for Dermatomyositis

Octagam 10% lands indication for adults following results of ProDERM trial

A box of Chantix (varenicline) tablets

FDA Warns Doctors, Consumers on Contaminated Chantix

Latest drug found with cancer-causing nitrosamines

FDA APPROVED Tacrolimus (Prograf) over a computer rendering of a lung in a metal dish with surgical tools.

FDA Breaks New Ground With Transplant Drug Approval

No prospective trial offered or required

FDA ADCOMM roxadustat over a computer renering of chronic kidney disease.

Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug

Advisory committee rejected oral anemia drug for dialysis and non-dialysis patient populations

FDA ADCOMM Transmedics OCS Liver over a photo of the device.

FDA Panel Nearly Unanimous on Liver Transplant Perfusion Device

Thumbs up on safety and efficacy

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

Company Shut Down Robot Mid-Surgery; Infected in Quarantine; Investigating Aduhelm

This past week in healthcare investigations

Four JUUL advertisements

Juul Bought Out Medical Journal for $51K

E-cig maker sponsored nearly a dozen studies, took over journal as it awaits FDA ruling

The YouTube video thumbnail with Dr. Zubin Damania and Vinay Prasad, MD, MPH, and the words IVERMECTIN& Aducanumab?

Ivermectin and Aducanumab: Do They Work?

ZDoggMD and Vinay Prasad, MD, MPH, analyze the evidence

The vial and packaging for NovoLog (insulin aspart) injection over a Walmart branded background.

Walmart's Low-Price Insulin Is a Band-Aid on a Broken System

Exorbitant drug pricing and inaccessible care require government intervention

FDA APPROVED finerenone (Kerendia) over a computer rendering of a diseased kidney and a healthy kidney.

Finerenone OK'd for Slowing Kidney Disease in T2D

Drug also indicated for cardiovascular event risk reduction

The vial and packaging of Aduhelm (aducanumab) for injection with blurred prescribing information in the background.

Alzheimer's Aducanumab Prescribing Information Changes

"We as neurologists need a strategy to advise our patients," experts say

An anatomical model head with brain exposed and electrodes attached to the temples.

FDA Cannot Ban Use of Electric Shock Devices for Harmful Behaviors

Appeals court rules in favor of only U.S. facility still using devices for behavioral treatment

A young pregnant woman takes a selfie with her smartphone while receiving the COVID-19 vaccine.

Is Confirmation Bias Guiding COVID Vaccine Recommendations?

Policy must be based on indisputable evidence

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

COVID Surges Emerge; FDA Warns About Chantix; Lions, Tigers, Bears Get Vaxxed

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

A male nurse gives a teen male a COVID-19 vaccination, both are wearing protective masks.

CDC's All-or-Nothing Approach to Teen COVID Vaccination Is All Wrong

The agency should revisit its latest guidance to maximize benefits and minimize risks

A bottle of (ranitidine) tablets spilled on a table.

Ranitidine Did Not Convert to Carcinogen in Two Small FDA Studies

However, don't expect the drug's return to market anytime soon, say editorialists

FDA ODAC over a PET scan of squamous carcinoma of the anal canal

Hold Off on Approving Anal Cancer Drug, Advisors Tell FDA

ODAC recommends deferring approval of new PD-1 inhibitor until confirmatory trial results are in

Cancer cells with OncoBreak in the center.

Start Thinking 'Cure'; One More Hug; Mortgages and Breast Cancer Survival

News, features, and commentary about cancer-related issues

An FDA APPROVED seal over a photo of prescription bottles on a shelf

The FDA Is Failing the American People

The agency's recent decision to approve aducanumab offers more evidence of a broken system

Vials of COVID-19 vaccine from various pharmaceutical companies.

Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines

Data should be from completed phase III trials, not interim results, group says

A waste basket view of a man throwing in a crumpled piece of paper

Op-Ed: Why Is Prescribing Information Still on Paper?

Making electronic info the default is a small change with a big environmental impact

FDA WARNING Medtronic HeartWare left ventricular assist device above a photo of the device in the palm of a mans hand

Medtronic's LVAD Pulled From Market Due to Neurological, Mortality Risks

Physicians must stop implanting the HeartWare system, says FDA

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

Guns for Vaccinations; IU Health Joins the Mandate Club; NFL Ends 'Race-Norming'

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

FDA MARKETING Cognoa ASD Diagnosis Aid (Canvas DX) over a photo of the software running on a smartphone

Novel Aid to Help Diagnose Autism Gets FDA Nod

Canvas Dx device may help early diagnoses and intervention in young children

FDA APPROVED olanzapine and samidorphan (Lybalvi)

FDA OKs New Antipsychotic for Schizophrenia, Bipolar Disorder

Approval of olanzapine-samidorphan carries opioid-related contraindications

A syringe sticking out of a vial of covid-19 vaccine with out of focus people waiting for their shot in the background

Are Vaccine Advisors More Conflicted Than We Thought?

Rules for advisory committee members' disclosures vary widely

FDA ADCOMM Teplizumab over a computer rendering of antibodies

Drug to Delay T1D Gets Tepid Endorsement by FDA Advisors

Feelings mixed on safety and efficacy evidence for novel biologic

FDA WARNING Obeticholic acid (Ocaliva) over two bottles of Ocaliva over a computer rendering of a liver with cirrhosis.

FDA Restricts Ocaliva Use in Primary Biliary Cholangitis

Liver failure, need for liver transplant reported in patients with advanced cirrhosis

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