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Washington Watch

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A photo of Monica Bertagnolli, MD from her nomination hearing.

<乌鸦传媒>Senate Committee Advances NIH Director Nominee to Full Senate

15-6 vote for Monica Bertagnolli, with chairman Sanders voting against the nominee

AAP over a photo of Walter E. Washington Convention Center in Washington, DC.

<乌鸦传媒>Lax Regulation, Colorful Packaging, Draw Minors to Delta-8 Cannabinoids Online

One-third of distributor sites did not ask customers their age

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

<乌鸦传媒>Misinfo Removal Continues; New Meningitis Vax Approved; Long COVID and Menopause

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

A screenshot of Frank Pallone speaking during this hearing.

<乌鸦传媒>House Members Mull Bills to Cut Red Tape and Improve Docs' Medicare Pay

But Democrats say they weren't given enough input in many of the measures

A screenshot of Senator Ron Wyden speaking during this hearing.

<乌鸦传媒>Shady Medicare Advantage Plan Tactics Blasted at Senate Hearing

"It's a rip-off and it's got to stop," one Senator said

The advertisement for this Instagram Live event.

<乌鸦传媒>IG Live October 23: Life in the Fast Lane With FDA's Accelerated Approvals

Experts share their perspectives on the increasingly controversial FDA pathway

A screenshot of Monica Bertagnolli, MD speaking during this hearing.

<乌鸦传媒>Senators Grill NIH Director Nominee on Drug Prices, Gender-Affirming Care

Monica Bertagnolli, MD, makes her case during confirmation hearing

FDA APPROVED pilocarpine hydrochloride ophthalmic solution (Qlosi) over a photo of a man struggling to see his phone.

<乌鸦传媒>Eye Drops for Presbyopia Win FDA Approval

Pilocarpine hydrochloride solution improved distance-corrected vision in two phase III trials

FDA APPROVED tenapanor (Xphozah) over a computer rendering of chronic kidney disease.

<乌鸦传媒>FDA Approves First Phosphate Absorption Inhibitor for CKD

Tenapanor indicated for adults on dialysis who fail on phosphate binders

FDA APPROVED pembrolizumab (Keytruda) + platinum-containing chemotherapy over a computer rendering of lung cancer.

<乌鸦传媒>Pembrolizumab Wins FDA Approval in Operable Lung Cancer

Checkpoint inhibitor demonstrated significant survival improvement in perioperative setting

IDWeek over a photo of Boston Convention & Exhibition Center - Boston, MA.

<乌鸦传媒>The Case for a Yearly COVID Booster Shot

New analysis of Moderna's COVE trial looked at best time for boosters

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

<乌鸦传媒>Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wage

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

FDA approved oral etrasimod (Velsipity) over a computer rendering of ulcerative colitis.

<乌鸦传媒>New Oral Drug Approved for Ulcerative Colitis in Adults

S1P receptor modulator etrasimod indicated for moderately to severely active disease

ACEP over the Penn medical buildings in Philadelphia.

<乌鸦传媒>Have a Story About Private Equity Ownership? The FTC Wants to Hear From You

The agency wants to even the healthcare playing field, says FTC chair Lina Khan

A photo of a laboratory technician slicing umbilical cord tissue samples.

<乌鸦传媒>FDA Warns That Umbilical Cord Injection Is a Drug

Company owner also has a stem cell clinic in Panama claiming to treat various conditions

FDA APPROVED encorafenib (Braftovi) over a computer rendering of lung cancer.

<乌鸦传媒>Combination Therapy Wins FDA Approval for BRAF-Mutated NSCLC

Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients

FDA WARNING Compounded ketamine products over a photo of a woman using nasal spray.

<乌鸦传媒>FDA Warns on Compounded Ketamine for Psych Disorders

The agency emphasized the drug is not approved for any psychiatric disorder

A purple ribbon next to the words: October is DOMESTIC VIOLENCE AWARENESS MONTH

<乌鸦传媒>Opposing Gun Ownership by Domestic Abusers Is My Lane

Commit to speaking out during Domestic Violence Awareness Month

HFSA over a photo of Huntington Convention Center in Cleveland, Ohio.

<乌鸦传媒>FDA Turns Down ATTR Cardiomyopathy Drug

Decision cites insufficient evidence of clinical meaningfulness

A photo of an addict on the street on Kensington Avenue in Philadelphia.

<乌鸦传媒>Trial Design, Treatment Options Spotlighted in Xylazine Conference

Clinical trials need to include more active users, researcher says

FDA ADCOMM sotorasib (Lumakras) over a chest x-ray image of a patient with lung cancer.

<乌鸦传媒>Sotorasib's Confirmatory Data in NSCLC Unreliable, Says FDA Panel

But聽agency doesn't plan to immediately push for KRAS inhibitor's withdrawal

A photo of a female physician at her desk counting a stack of $100 bills.

<乌鸦传媒>Should 'Site Neutrality' Be Used to Set Payments? MedPAC Members Disagree

"I don't think 'site-neutral' is neutral," one commissioner says

FDA ODAC eflornithine (DFMO) over a photo of a little girl battling neuroblastoma.

<乌鸦传媒>FDA Panel Endorses DFMO for Kids' High-Risk Neuroblastoma in Remission

Large improvement in event-free survival, but questions linger about sources of data

A photo of a bottle of Exkivity capsules over a computer rendering of lung cancer.

<乌鸦传媒>Drugmaker Plans to Pull Lung Cancer Therapy From the Market

Randomized trial of mobocertinib (Exkivity) failed to confirm聽benefit in rare tumor type

A photo of striking healthcare workers outside of Kaiser Permanente Zion Medical Center in San Diego

<乌鸦传媒>Coast to Coast, Kaiser Permanente Workers Start 3-Day Strike

Employees picket, complain of staff shortages, burnout, low pay, and low morale

FDA ADCOMM sotorasib (Lumakras) over a chest x-ray image of a patient with lung cancer.

<乌鸦传媒>FDA Staff Highly Skeptical of Confirmatory Data on KRAS Inhibitor in NSCLC

Reviewers see potentially tiny PFS benefit with sotorasib, raise concerns over "systemic bias"

FDA EUA Novavax COVID-19 Vaccine over a photo of a person holding a vial of Nuvaxovid.

<乌鸦传媒>Novavax's Updated COVID Shot Authorized by FDA

Protein-based vaccine is refreshed with 2023-2024 formula targeting XBB strain

FDA ODAC eflornithine (DFMO) over a photo of a little girl battling neuroblastoma.

<乌鸦传媒>FDA Advisors to Consider DFMO Maintenance for High-Risk Neuroblastoma in Kids

Lack of options for relapsed disease versus uncertainty about supporting data

A computer rendering of RSV viruses.

<乌鸦传媒>A Framework to Communicate With Pregnant Patients About the RSV Vaccine

A values-based decision-making framework is key

FDA MARKETING Invitae Common Hereditary Cancers Panel over a photo of the product.

<乌鸦传媒>FDA Greenlights Test for Cancer-Predisposing Genetic Mutations

First-of-its-kind DNA test achieved 99% accuracy for variants in dozens of genes

FDA APPROVED nedosiran (Rivfloza) over a computer rendering of a transparent kidney with kidney stones.

<乌鸦传媒>FDA OKs Another Injectable for Rare Kidney Disorder

Nedosiran approved for patients ages 9 years and older with primary hyperoxaluria type 1

A photo of a female healthcare worker preparing a COVID booster shot.

<乌鸦传媒>Clean Up the COVID Booster Mess by Returning to a Single-Payer System

We must reopen the door to easy preventive care access

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

<乌鸦传媒>AMA Too Woke? FDA Warns on Probiotics; Medicare Drug-Price Negotiation Moves Forward

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

A photo of a female lab technician preparing samples for PCR diagnostics

<乌鸦传媒>Lab Tests That Escape FDA Oversight May Come Under Agency Review

Agency proposes tighter oversight of laboratory developed tests

A photo of senator Dianne Feinstein

<乌鸦传媒>Senator Dianne Feinstein Dies at 90

Accomplishments included helping pass assault weapons ban, ACA, protecting kids from phthalates

FDA APPROVED cipaglucosidase alfa (Pombiliti) plus miglustat (Opfolda) over a muscle biopsy showing accumulation of glycogen.

<乌鸦传媒>New Option OK'd for Pompe Disease

FDA approves two-component therapy for patients not improving on enzyme replacement therapy

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

<乌鸦传媒>Dianne Feinstein Dies; Prison for Alzheimer's Fraudsters; Kaiser Strike Looming

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

FDA APPROVED gepirone hydrochloride extended-release (Exxua) over a photo of a woman covering her face with her hands.

<乌鸦传媒>FDA Relents, Approves Novel Antidepressant After Many Rejections

Gepirone extended-release approved after nearly 2 decades of trying

A screenshot of Kevin Kiley speaking during this hearing.

<乌鸦传媒>OSHA Comes in for Both Praise and Harsh Criticism at House Hearing

Illinois lawmaker calls agency head "inept" during discussion of COVID vaccine mandate rule

A photo of an Ozempic injection pen laying on a marble countertop.

<乌鸦传媒>FDA Adds Intestinal Blockage Reports to Ozempic Labeling

Joins other approved GLP-1 receptor agonists in noting the potential adverse reaction

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