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FDA General

FDA ADCOMM RSV vaccine safety in pediatric populations over a computer rendering of RSV virus particles.

<乌鸦传媒>FDA Advisors Say More Data Needed for RSV Vaccines in Young Kids

A "very complicated situation" after mRNA vaccine trial was halted, expert says

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

<乌鸦传媒>RFK Jr.'s Lawyer Asked FDA to Pull Polio Vaccine; Pollution-VTE Link; H5N1 in Cats

Health news and commentary gathered by 乌鸦传媒 staff

FDA SAFETY obeticholic acid (Ocaliva) over a photo of the product over a computer rendering of the biliary tree.

<乌鸦传媒>FDA Issues Safety Alert on Liver Disease Drug

Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis

A photo of a female physician writing a prescription.

<乌鸦传媒>Providers, You Are the Missing Piece: Your Patients With OUD Need You

Resources and treatment are essential to addressing the overdose crisis

A screenshot of Bernie Sanders speaking during this hearing.

<乌鸦传媒>FDA Panned at Senate Hearing for Failure to Address Diabetes, Obesity Epidemics

Agency has failed to hold food manufacturers accountable, said Sen. Bernie Sanders

FDA APPROVED durvalumab (Imfinzi) over a computer rendering of lung cancer.

<乌鸦传媒>Durvalumab Wins FDA Approval in Limited-Stage SCLC

Unprecedented 22.5-month improvement in median overall survival as consolidation therapy

FDA APPROVED zenocutuzumab-zbco (Bizengri) over a computer rendering of monoclonal antibodies attacking cancer cells.

<乌鸦传媒>FDA OKs First Drug Targeting NRG1 Gene Fusion in Pancreatic, Lung Cancers

Zenocutuzumab achieved response rates of 40% in pancreatic adenocarcinoma, 33% in advanced NSCLC

A photo of the the Supreme Court building in Washington, Nov. 2, 2024.

<乌鸦传媒>Supreme Court Doesn't Seem Convinced FDA Was Unfair in Blocking Flavored Vapes

Companies say agency changed its standards with little warning as it blocked sale of new products

3-D rendering of Florida.

<乌鸦传媒>Florida's Canadian Drug Import Plan Goes Nowhere After FDA Approval

A year after being greenlit, the program has yet to begin

A photo of a woman holding her boy who suffers from adrenoleukodystrophy.

<乌鸦传媒>FDA Investigating Blood Cancer Risk With Gene Therapy Skysona

Agency is evaluating the need for further regulatory action

Image of the vegetable department of a grocery store.

<乌鸦传媒>Have Foodborne Illness Outbreaks Really Increased?

The answer may have more to do with how we track them, experts say

Attruby is an orally administered near-complete stabiliser of TTR.

<乌鸦传媒>Acoramidis Snags FDA Approval for ATTR Cardiomyopathy

Another pricey TTR stabilizer to hit shelves

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

<乌鸦传媒>Dr. Oz's Dubious Claims; Bird Flu Found in Raw Milk; Whooping Cough Surges

Health news and commentary gathered by 乌鸦传媒 staff

A computer rendering of a robot hand holding a sphere which contains a medical shield and cross.

<乌鸦传媒>Digital Doctors Are Coming. Regulators Need to Catch Up.

We must ensure AI advances in medicine in a way that's safe, fair, and beneficial for all

A photo of Marty Makary, MD, MPH.

<乌鸦传媒>Trump's FDA Pick Is 乌鸦传媒's Former Top Editor

Marty Makary has made a name for himself challenging the medical establishment

FDA ADCOMM Artificial intelligence-enabled medical devices over a photo of a male physician holding a transparent tablet.

<乌鸦传媒>New FDA Panel Weighs In on Regulating Generative AI in Healthcare

Committee's 2-day meeting focused on evaluating and monitoring performance and risk

A computer rendering of a transparent body with several skeletal joints highlighted.

<乌鸦传媒>Lack of Clinical Benefit of Andexanet Flummoxes FDA Panel

Yet advisors were not inclined to take back approval for bleeding reversal agent

A close up photo of Marlboro Menthol cigarettes protruding from the box.

<乌鸦传媒>What's the Status of the Proposed Ban on Menthol Cigarettes?

No one is saying for certain; a final rule is in process but has yet to be issued

A photo of Donald Trump.

<乌鸦传媒>Trump Is Back: What This Could Mean for Health Policy

Exploring the powers and limits of the Presidency

FDA APPROVED zanidatamab (Ziihera) over a computer rendering of the gall bladder.

<乌鸦传媒>FDA Approves Zanidatamab for Biliary Tract Cancer

New antibody indicated for previously treated, unresectable or metastatic HER2-positive disease

FDA ADCOMM clozapine over a photo of a blisterpack of yellow tablets.

<乌鸦传媒>Scrap Clozapine's REMS Program, FDA Advisors Say

Panel wants to reduce barriers to the only drug indicated for treatment-resistant schizophrenia

A photo of Robert F. Kennedy Jr.

<乌鸦传媒>Scientists Fear What's Next for Public Health if RFK Jr. Is Allowed to 'Go Wild'

One expert believes we're returning to "every man his own doctor"

FDA APPROVED revumenib (Revuforj) over a computer rendering of leukemia cells.

<乌鸦传媒>FDA Approves First Menin Inhibitor for Acute Leukemia

Complete responses in 21% of patients treated with single-agent revumenib

FDA ADCOMM clozapine over a photo of a blisterpack of yellow tablets.

<乌鸦传媒>Clozapine's REMS Program on the Chopping Block at Upcoming FDA Meeting

Can severe neutropenia associated with the schizophrenia drug be monitored without it?

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

<乌鸦传媒>RFK Jr. Spurs FDA Resignations; Chatbot to User: 'Please Die'; Dating Apps and STIs

Health news and commentary gathered by 乌鸦传媒 staff

FDA APPROVED eladocagene exuparvovec-tneq (Kebilidi) over a computer rendering of nerve cells.

<乌鸦传媒>First Brain-Delivered Gene Therapy Approved for AADC Deficiency

Novel treatment is indicated for children and adults with the rare disorder

This combination of images from video shows scenes from Nasonex television commercials broadcast in the U.S. in the 2000s.

<乌鸦传媒>New FDA Rules for TV Drug Ads: Simpler Language and No Distractions

Agency spent over 15 years crafting the guidelines

A photo of bottles of Ocaliva tablets over a computer rendering of the gallbladder with bile duct and biliary tree.

<乌鸦传媒>FDA Rejects Full Approval of Liver Disease Drug

Agency's decision on obeticholic acid in PBC follows negative advisory committee meeting

A photo of mifepristone tablets in a Planned Parenthood clinic July 18, 2024, in Ames, Iowa.

<乌鸦传媒>Anti-Abortion Groups Press Trump for More Restrictions as Abortion Pill Sales Spike

Advocates look to undo Biden administration's policies

FDA APPROVED obecabtagene autoleucel (Aucatzyl) over a rendering of CAR-T cells attacking lymphoblastic leukemia cells.

<乌鸦传媒>New CAR T-Cell Therapy Approved for Leukemia

Obecabtagene autoleucel has no requirement for a REMS program

A close up photo of a needle of a semaglutide injection pen.

<乌鸦传媒>FDA Adds New Warning to GLP-1 Drugs

Labels now caution about pulmonary aspiration risk

FDA ADCOMM ProSense cryoablation system over a computer rendering of the device freezing a breast tumor.

<乌鸦传媒>FDA Panel Backs Cryoablation in Early Breast Cancer as Alternative to Surgery

ProSense device would be indicated with adjuvant endocrine therapy for some low-risk patients

A photo of cold and allergy medication on the shelf at a Walgreens.

<乌鸦传媒>FDA Plans to Ban Popular Cold Med

Data review shows that oral phenylephrine is not effective as a decongestant, agency says

A photo of an empty White House press briefing room.

<乌鸦传媒>Election Redux: Public Health Just Got a Lot More Difficult

We must continue to fight

FDA MARKETING Light delivery system (Valeda) over photos of the product.

<乌鸦传媒>FDA Grants Market Authorization to Light-Therapy System for Dry AMD

Valeda photobiomodulation system slowed disease progression and improved vision

A photo of Donald Trump.

<乌鸦传媒>What Trump Has Proposed for Healthcare in a Second Administration

A look at Trump's history and ideas floated on the campaign trail

FDA APPROVED minocycline hydrochloride extended-release capsules (Emrosi) over a photo of a woman with rosacea on her cheeks

<乌鸦传媒>FDA Approves New Option for Rosacea

Antibiotic Emrosi topped doxycycline, placebo in phase III trials

A photo of Donald Trump shaking hands with Robert F. Kennedy Jr. during a rally in Duluth, Georgia.

<乌鸦传媒>RFK Jr. Threatens the Very Fabric of Healthcare

A vote to give Kennedy power is a vote against public health

<乌鸦传媒>How the Election Results Could Affect Healthcare in the U.S.

Anand Parekh breaks down the possible futures for abortion rights, EMTALA, and Obamacare

A photo of Donald Trump in the Oval Office.

<乌鸦传媒>What Will CDC, FDA, and CMS Look Like After the Election?

We talked to healthcare experts to get their predictions for a Trump or Harris administration

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