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Washington Watch

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<乌鸦传媒>FDA Yanks Only Preterm Birth Drug, Effective Immediately

Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision

A screenshot of a Medicare Advantage television commercial featuring Joe Namath.

<乌鸦传媒>CMS Cracks Down on Medicare Advantage Marketing, Prior Auth Practices

Agency wants to stop schemes that mislead beneficiaries and prohibit unfair denials of care

A photo of a Drug Enforcement Administration officer鈥檚 black jacket.

<乌鸦传媒>New DEA License Requirement Starts in June

The X waiver is gone, but clinicians may need new training to renew their DEA license

A photo of a surgeon holding a kidney prior to transplantation.

<乌鸦传媒>Monopoly Be Gone: A New Chapter in U.S. Organ Procurement and Transplantation

A recent announcement from HHS has the power to transform our deeply flawed system

A photo of a senior man putting a white box into a padded envelope.

<乌鸦传媒>Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scripts

Strategy will provide another option to dispose of unneeded medications, FDA says

A screenshot of Robin Feldman speaking during this hearing.

<乌鸦传媒>Experts Call for PBM Transparency During Senate Hearing

"Every drug should have a price that is accessible to every American at any time," witness argues

A photo of the entrance to the Moderna headquarters in Cambridge, MA.

<乌鸦传媒>Moderna's Steep COVID Vaccine Price: Corporate Greed or Capitalism?

Lessons learned and next steps for public-private vaccines

FDA ADCOMM isotretinoin REMS (iPledge) over a close up photo of a woman with severe acne on her face.

<乌鸦传媒>Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urge

It's an "unduly high burden" on patients, says one advisory committee member

A photo of police vehicles blocking the entrance to the Covenant Presbyterian Church and school in Nashville Tennessee.

<乌鸦传媒>'No Safe Place': Shooting Hits Home for Nashville Doctors

Pediatric surgeon: "Why are our children being massacred in their schools?"

FDA ADCOMM isotretinoin REMS (iPledge) over a close up photo of a woman with severe acne on her face.

<乌鸦传媒>Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Says

Report suggests ways to lighten documentation rules for prescribing the severe acne treatment

FDA APPROVED leniolisib (Joenja) over a photo of a female physician palpating her mature male patients lymph nodes.

<乌鸦传媒>FDA Greenlights First Drug for Rare Immunodeficiency Disease

Activated PI3K-delta syndrome may have a new standard of care

A photo of the Olympus single-use duodenoscope

<乌鸦传媒>FDA Faults Next-Gen Olympus Duodenoscopes

After demanding single-use devices, agency finds they have their own problems

FDA SAFETY Exactech joint replacement devices over a photo of Exactech knee replacement devices

<乌鸦传媒>FDA: Watch for Joint Replacement Device Failure After Exactech Recall

Revision surgery only recommended for patients with pain

A computer rendering of two generic health and dental insurance cards.

<乌鸦传媒>A Conservative Blueprint for Universal Healthcare

Achieving universal coverage is possible using the ACA as a framework

FDA APPROVED tofersen over a computer rendering of a damaged motor neuron.

<乌鸦传媒>FDA Panel Supports Tofersen for Rare Genetic ALS

In a first, agency advisors back neurofilament light as a surrogate endpoint

A photo of a surgeon holding a kidney prior to it鈥檚 implantation.

<乌鸦传媒>Biden Administration Announces Plan to Overhaul the Organ Transplant System

Steps include making contracting more competitive and publishing donation data

FDA APPROVED retifanlimab (Zynyz) over a photo of a woman with Merkel cell carcinoma on her ear

<乌鸦传媒>FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinoma

Retifanlimab produced responses in 52% of patients with untreated unresectable disease

A photo of the signage outside of the FDA headquarters in Washington, D.C.

<乌鸦传媒>FDA Has Neglected Clinical Trial Transparency 鈥� Plus $45 Billion in Fines

It's time for more aggressive enforcement of the law

FDA ADCOMM tofersen over a computer rendering of a damaged motor neuron.

<乌鸦传媒>Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says

Neurofilament light will be evaluated as a surrogate endpoint in tofersen review

FDA MARKETING Copenhagen Classic Snuff over a photo of a man opening a can of snuff.

<乌鸦传媒>FDA Allows Lower Risk Designation for Snuff Product

The brand joins a limited few granted modified risk tobacco claims

A photo of Kate Pierce speaking at this hearing.

<乌鸦传媒>More Money, Better Standards Needed to Improve Health Cybersecurity, Senators Told

Small rural hospitals especially at risk, witness says

A photo of Joseph Ladapo, MD, PhD

<乌鸦传媒>CDC, FDA Heads Fire Back at Ladapo Letter

Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading"

A photo of a mature female physician holding papers and looking at a computer monitor.

<乌鸦传媒>A Third of Docs Blame Prior Authorizations for Serious Harm to Patients

Four in five say they waste resources, forcing use of ineffective treatments, extra visits

A photo of a mature female physician asleep at her desk.

<乌鸦传媒>AMA, Surgeon General Propose Ways to Prevent Doctor Burnout

Get enough sleep, stop prior authorization, and share your story with colleagues

FDA ODAC polatuzumab vedotin (Polivy) over a microscopy of B-cell lymphoma cells.

<乌鸦传媒>FDA Panel Endorses New First-Line Lymphoma Regimen

POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say

FDA APPROVED Bimodal neuromodulation device (Lenire) over a photo of a man using the Lenire device.

<乌鸦传媒>First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod

Ringing ears may get relief with sound and tongue stimulation

<乌鸦传媒>Only Drug to Prevent Preterm Birth Set to Leave the Market

Decision follows FDA advisory committee recommendation for withdrawal

FDA ODAC polatuzumab vedotin-piiq (Polivy) over a micrograph of diffuse large B-cell lymphoma

<乌鸦传媒>FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimen

Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty"

A photo of loose tablets next to a prescription bottle of hydrocodone/APAP tablets.

<乌鸦传媒>FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effective

Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose

A photo of Stella Immanuel, MD

<乌鸦传媒>Stella Immanuel Highest U.S. Prescriber of Ivermectin and HCQ

Controversial physician has doled out tens of thousands of scripts for both drugs

A photo of an open ICD code book.

<乌鸦传媒>Expanding ICD Codes May Aid Rare Disease Patients, Research

NCATS explores how best to use diagnostic codes to move field forward

A screenshot of Marty Makary, MD, MPH, speaking during this hearing.

<乌鸦传媒>Hopkins' Makary Tells Lawmakers COVID Lab Leak a 'No-Brainer'

Other expert witnesses open to other origin theories

FDA APPROVED omaveloxolone (Skyclarys) over a photo of a man with Friedreich鈥檚 ataxia in a wheelchair outside.

<乌鸦传媒>First Treatment Approved for Rare Neurodegenerative Disorder

Omaveloxolone gets FDA nod for Friedreich's ataxia

FDA ADCOMM omecamtiv mecarbil over a computer rendering of a heart attack.

<乌鸦传媒>Omecamtiv Mecarbil for Heart Failure Turned Down by FDA

End of the road for cardiac myosin activator

A photo of a vial of xylazine on the counter in a veterinary clinic

<乌鸦传媒>FDA Issues Import Alert on 'Tranq' Drug Xylazine

Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>Docs Push Ivermectin for Flu; Woody's SNL Intro; Energy Dept. Backs Lab Leak Theory

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

A photo of a female nurse weighing a pregnant woman while her daughter looks at a smartphone.

<乌鸦传媒>Disparities in Maternal Mortality? 'We Know Exactly What to Do,' Says Lawmaker

Black women are three times more likely to die in childbirth

A photo of a woman holding a mifepristone tablet in her hand next to the box.

<乌鸦传媒>A Ban on the Abortion Drug Mifepristone Is Looming

A Texas lawsuit may be disastrous for effective abortion access and FDA's authority

A photo of a box of Narcan Nasal Spray sitting on a marble counter top.

<乌鸦传媒>Over-the-Counter Naloxone Has the Power to Save Lives

But removing barriers to access is an essential next step

Legal Break over a blindfolded Lady Justice statue holding scales.

<乌鸦传媒>Third Doctor Arrested for U.S. Capitol Riot; Pediatrician Sues for 'Anti-Male' Bias

A weekly roundup of healthcare's encounters with the courts

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