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FDA General

A computer rendering of antibodies attacking a COVID virus.

FDA Revokes EUAs of Four COVID-19 Monoclonal Antibodies

Mostly expired drugs are no longer effective against circulating SARS-CoV-2 strains

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

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.

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

Health news and commentary gathered by MedPage Today staff

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Dr. Oz's Dubious Claims; Bird Flu Found in Raw Milk; Whooping Cough Surges

Health news and commentary gathered by MedPage Today staff

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

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.

Trump's FDA Pick Is MedPage Today'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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

RFK Jr. Spurs FDA Resignations; Chatbot to User: 'Please Die'; Dating Apps and STIs

Health news and commentary gathered by MedPage Today staff

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

RFK Jr. Threatens the Very Fabric of Healthcare

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

How the Election Results Could Affect Healthcare in the U.S.

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

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