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FDA Approves First Menin Inhibitor for Acute Leukemia

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

Nov 15, 2024
FDA APPROVED revumenib (Revuforj) over a computer rendering of leukemia cells.
Clozapine's REMS Program on the Chopping Block at Upcoming FDA Meeting

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

Nov 15, 2024
FDA ADCOMM clozapine over a photo of a blisterpack of yellow tablets.
RFK Jr. Spurs FDA Resignations; Chatbot to User: 'Please Die'; Dating Apps and STIs

Health news and commentary gathered by ѻý staff

Nov 15, 2024
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.
First Brain-Delivered Gene Therapy Approved for AADC Deficiency

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

Nov 14, 2024
FDA APPROVED eladocagene exuparvovec-tneq (Kebilidi) over a computer rendering of nerve cells.
New FDA Rules for TV Drug Ads: Simpler Language and No Distractions

Agency spent over 15 years crafting the guidelines

Nov 14, 2024
 This combination of images from video shows scenes from Nasonex television commercials broadcast in the U.S. in the 2000s.
FDA Rejects Full Approval of Liver Disease Drug

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

Nov 12, 2024
A photo of bottles of Ocaliva tablets over a computer rendering of the gallbladder with bile duct and biliary tree.
Anti-Abortion Groups Press Trump for More Restrictions as Abortion Pill Sales Spike

Advocates look to undo Biden administration's policies

Nov 11, 2024
A photo of mifepristone tablets in a Planned Parenthood clinic July 18, 2024, in Ames, Iowa.
New CAR T-Cell Therapy Approved for Leukemia

Obecabtagene autoleucel has no requirement for a REMS program

Nov 08, 2024
FDA APPROVED obecabtagene autoleucel (Aucatzyl) over a rendering of CAR-T cells attacking lymphoblastic leukemia cells.
FDA Adds New Warning to GLP-1 Drugs

Labels now caution about pulmonary aspiration risk

Nov 08, 2024
A close up photo of a needle of a semaglutide injection pen.
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

Nov 08, 2024
FDA ADCOMM ProSense cryoablation system over a computer rendering of the device freezing a breast tumor.
FDA Plans to Ban Popular Cold Med

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

Nov 07, 2024
 A photo of cold and allergy medication on the shelf at a Walgreens.
FDA Grants Market Authorization to Light-Therapy System for Dry AMD

Valeda photobiomodulation system slowed disease progression and improved vision

Nov 06, 2024
FDA MARKETING Light delivery system (Valeda) over photos of the product.
What Trump Has Proposed for Healthcare in a Second Administration

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

Nov 06, 2024
A photo of Donald Trump.
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