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FDA General

FDA WARNING Needle-Free Devices for Injection of Dermal Fillers over a photo of a woman receiving lip filler via hyaluron pe

FDA Warns on Needle-Free Injection Devices for Facial Fillers

Serious injuries and "irreversible" harm to skin, lips, and eyes reported with unapproved devices

FDA APPROVED avacopan (Tavneos) over a photo of a man鈥檚 foot showing vasculitis.

FDA Gives Thumbs Up to ANCA-Associated Vasculitis Drug

Approval granted to avacopan despite advisory committee concerns

A photo of the Medtronic 670G insulin pump

Back-to-Back Recalls for Medtronic Insulin Pumps

Class I recalls on 600 series pumps and 500 series remotes

FDA APPROVED Siemens Naeotom Alpha over an image of a senior man in a CT scanner.

FDA Clears 'Major Advancement' in CT Imaging

New Siemens' CT scanner is first allowed by agency with photon-counting detectors

Two bags of blood platelets.

The Cost of Blood Platelets Is About to Surge

FDA's flawed new guidance for blood transfusion safety takes effect October 1

Two computer rendered cigarette packs with graphic warning labels.

How Many Deaths Will New Cigarette Warnings Prevent?

Modeling study comes up with big numbers

A vial of the Moderna COVID-19 vaccine on an orange and a vial of the Pfizer-BioNTech COVID-19 vaccine on an apple.

I Got Moderna. Can I Boost With Pfizer?

"There's all sorts of anarchy going on"

FDA APPROVED Ruxolitinib (Opzelura) over a photo of atopic dermatitis on a man鈥檚 arm

FDA Approves First Topical JAK Inhibitor for Atopic Dermatitis

Significant skin clearance, reduced itch in majority of patients treated with ruxolitinib cream

The Supplement Facts from a phenibut supplemental product.

Unapproved Drug Found in Dietary Supplements Despite FDA Warning

Phenibut was found in all four products analyzed, with increased quantities in three

FDA RECALL Medtronic Pipeline Flex + Pipeline Flex with Shield Technology over a computer rendering of the device.

Pipeline Flex Endovascular Flow Diverters Under Recall

Serious injury and death linked to fracturing issue in the delivery system, FDA warns

Two white rubber gloved hands pour yellow and blue liquids from beakers into another vessel.

The Technological Marvel of Combination Vaccines

Many questions remain for co-formulating COVID vaccines, but pursuing this now is the right move

A syringe and seven vials of Comirnaty COVID-19 vaccine.

Pfizer Makes Its Case for COVID Booster Shots

Ahead of advisory meeting, FDA staff notes "inferred" effectiveness, and no new safety concerns

FDA ADCOMM AAV Gene Therapies over a computer rendering of neurons.

Gene Therapies Require Neurologic Monitoring

Nerve conduction, MRI monitoring may mitigate neurotoxicity risks

FDA ADCOMM AAV Gene Therapies over a computer rendering of the liver anatomy.

Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteria

FDA panel weighs in on lower vector doses and role of animal studies

COVID-19 vaccination record card with syringe and vial.

Take Another Look at the Spacing Between COVID Vaccine Doses

Growing body of research suggests robust immune response with extended dosing interval

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 APPROVED MicroTransponder Vivistim Paired VNS System (Vivistim System) over a photo and computer rendering of the device

Novel Stroke Rehab Treatment Wins FDA Approval

Neurostim system approved for upper limb deficits

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

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