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FDA General

FDA RECALL Obsidio Conformable Embolic over a computer rendering of the product.

FDA Slaps Embolization Device With Class I Recall After Deaths

Increased bowel ischemia risk when Obsidio Embolic is used for lower GI bleeds

AAN over a photo of Colorado Convention Center in Denver, CO

Why an ALS Drug Was Pulled From the Market

Topline data show where sodium phenylbutyrate and taurursodiol fell short

A photo of Holstein dairy cows in an outdoor feeding pen in Texas

The H5N1 Outbreak Is Not a Test Run, It's a Warning Shot

A true public health success would be preventing the virus from further adapting to humans

A photo of a line of Holstein dairy cows feeding through a fence at a dairy farm in Idaho

Bird Flu Is Spreading to More Farm Animals. Are Milk and Eggs Safe?

Health officials say the risk to the public is low and the food supply remains safe

A screenshot of Robert Califf, MD, speaking during this hearing.

FDA Chief Blasted for Infant Formula Crisis Response, COVID Vaccines

Republican lawmakers questioned why the agency is "failing to do the bare minimum"

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

Doc Fired After Deaths; Mass Shooting Blamed on Abortion Law; Record Drug Shortages

Health news and commentary from around the Web gathered by MedPage Today staff

FDA APPROVED benralizumab (Fasenra) over a computer rendering of an inflamed bronchial tube.

FDA Expands Approval of Severe Asthma Drug

Add-on maintenance therapy benralizumab now indicated for children ages 6 to 11 years as well

A photo of Jeffrey Reed at home next to his Philips continuous positive airway pressure (CPAP) machine.

After Massive CPAP Recall, Philips Ordered to Overhaul Manufacturing

More than 5 million machines have been recalled since 2021

FDA APPROVED ciltacabtagene autoleucel (Carvykti), idecabtagene vicleucel (Abecma) over 3D multiple myeloma cells.

FDA Approves Earlier Use of CAR-T Products for Myeloma

Carvykti and Abecma move to second- and third-line, respectively

A close up photo of two Wegovy injection pens.

Medicare Can Cover Anti-Obesity Drugs for Heart Disease -- But at What Cost?

Intense demand coupled with high costs may place pressures on CMS for years to come

AACR over a photo of San Diego Convention Center in San Diego, CA

Most Cancer Drugs Granted Accelerated Approval Fail Confirmatory Trials

Only 43% showed clinical benefit within 5 years

FDA APPROVED trastuzumab deruxtecan (Enhertu) over a computer rendering of antibodies attacking cancer cells

Enhertu Gets Tumor-Agnostic FDA Approval for HER2-Positive Cancers

About half of patients responded, duration of response as long as 19 months in three trials

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

More Bird Flu Spread; FDA to Allow Gay Men to Donate Sperm; 'Oatzempic' Trend

Health news and commentary from around the Web gathered by MedPage Today staff

A photo of the AvertD test kit.

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

Methodology behind AvertD DNA test questioned

A photo of a box of taurursodiol (Relyvrio)

ALS Therapy to Be Pulled From the Market, Drugmaker Says

Patients currently using Relyvrio can transition to a free drug program, Amylyx said

FDA APPROVED danicopan (Voydeya) over a computer rendering of red blood cells.

Factor D Inhibitor Wins Approval for PNH With Extravascular Hemolysis

Danicopan significantly improved hemoglobin at 12 weeks when added to a C5 inhibitor

FDA APPROVED ceftobiprole medocaril sodium (Zevtera) over a computer rendering of Staphylococcus aureus bacteria

FDA OKs Injectable Antibiotic for Three Different Uses

Ceftobiprole was at least comparable to currently used medications in studies

A photo of a Zepbound injection pen.

Weight-Loss Drug Zepbound Faces Supply Issues

Following weight-loss indication, patients struggle to obtain tirzepatide

A photo of New York State Psychiatric Institute in New York City

FDA Warning Letters Detail Controversy at Psychiatric Institute

Two letters - one to a psychiatrist - follow reports of a trial participant's suicide

A photo of a man’s arm with an intravenous line attached dangling off the edge of a couch.

Are Federal Agencies Coming for Ketamine Clinics?

Compliance plans can help in the face of possible regulatory scrutiny

Photo of a man with a continuous glucose monitor on his arm.

Here's What OTC Continuous Glucose Monitors Can Do for Our Patients

FDA's approval may be a step toward greater access

FDA APPROVED sotatercept (Winrevair) over computed tomography angiography of the pulmonary arteries

Sotatercept's FDA Approval a New Chapter for Pulmonary Arterial Hypertension

Biologic should arrive on pharmacy shelves before May

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

FDA Questioned on Elon Musk's Neuralink; OTC Pain Relief Warning; Easter Egg Safety

Health news and commentary from around the Web gathered by MedPage Today staff

A photo of a vial of Fluorouracil

Overdosing on Chemo: A Common Gene Test Could Save Hundreds of Lives Each Year

Treatment can be deadly for enzyme-deficient patients; NCCN doesn't call for preemptive testing

A photo of the electrodes of an Electrical Stimulation Device

FDA Again Tries to Ban 'Aversive' Shock Treatment

Agency proposed a new ban to eliminate shock therapy for self-injurious or aggressive behavior

A photo of a female physician talking to her young female patient via a laptop.

More Medication Prescribed for Self-Managed Abortion After Roe Fell

While in-clinic abortions fell, many found other ways to access care

A photo of boxes of the drug mifepristone on a shelf

SCOTUS Again Takes on Issue of Abortion, This Time Over Mifepristone Access

Law professor says the case has the potential to upend how drug approvals function

FDA APPROVED macitentan/tadalafil (Opsynvi) over a computer rendering of the pulmonary arteries

Fixed-Dose Macitentan/Tadalafil Combo Gets FDA Approval for PAH

Opsynvi puts two drugs commonly prescribed for pulmonary arterial hypertension into one tablet

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

FDA Settles Ivermectin Case; When AI Makes a Medical Error; $97,000 Air Ambulance

Health news and commentary from around the Web gathered by MedPage Today staff

FDA EUA pemivibart (Pemgarda) over a computer rendering of antibodies attacking COVID viruses.

New Monoclonal Authorized to Prevent COVID in Immunocompromised People

No such option has been available since FDA revoked the authorization of Evusheld last year

FDA APPROVED oral givinostat (Duvyzat) over an anatomical model of the proximal muscles of the male body

Novel Drug Approved for All Duchenne Muscular Dystrophy Variants

Givinostat is the first nonsteroidal drug approved for DMD regardless of genetic mutation

FDA APPROVED bempedoic acid (Nexletol) over a computer rendering of a heart attack.

Expanded Label Officially Makes Bempedoic Acid a CVD Prevention Medication

New indications supported by CLEAR Outcomes trial

FDA APPROVED ponatinib (Iclusig) over a computer rendering of the destruction of lymphoblast cells

FDA Approves New Frontline Regimen for Aggressive ALL

Ponatinib lands indication in combination with chemo for Philadelphia chromosome-positive cases

A photo of proposed cigarette warning labels.

Graphic Images on Cigarettes of Smoking's Harm Are Constitutional, Court Rules

Partial victory for federal regulators seeking to toughen warning labels

A photo of Cathy McMorris Rodgers speaking during this hearing.

House Committee Wrestles With Lab Test Regulation

Some favor a proposed FDA rule, while others push for passage of the VALID Act

A screenshot of Xavier Becerra speaking during this hearing.

GOP Lawmakers Blast HHS, Biden for Plans to Loosen Marijuana Restrictions

Opposition to Medicaid work requirements also came on the table at a House hearing

FDA RECALL Impella left-sided blood pumps: Instructions For Use (IFU) over a computer rendering of the device

Wider Pool of Impella Heart Pumps Caught in Recall After 49 Deaths

Devices require label correction for left ventricle perforation risk

FDA APPROVED aprocitentan (Tryvio) over a photo of a man wearing a sphygmomanometer displaying a high blood pressure reading

Novel Oral Antihypertensive Gets FDA's Blessing

Aprocitentan becomes the first endothelin receptor antagonist for BP lowering

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

Kate Middleton's Medical Records; FDA Syringe Warning; NIH Ends COVID Guidelines

Health news and commentary from around the Web gathered by MedPage Today staff

FDA approved atidarsagene autotemcel (Lenmeldy) over a computer rendering of a motor neuron.

Pediatric Neuron Disease Gets Its First Gene Therapy

FDA approves arsa-cel for metachromatic leukodystrophy

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