Public Health & Policy

FDA General

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FDA Panel Gives Strong Backing to RSV Vaccine for Protecting Infants

If it lives up to its promise, many infants and parents "will breathe easier," says panelist

May 18, 2023
FDA ADCOMM maternal RSV vaccine over a computer rendering of respiratory syncytial virus.
Opinion
Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy?

Waiting for the results of the SRP-9001 confirmatory trial may be a better move

May 18, 2023
A photo of a little boy in a wheelchair.
First JAK Inhibitor Approved for Crohn's Disease

Upadacitinib lands indication for moderately to severely active disease in adults

May 18, 2023
FDA APPROVED upadacitinib (Rinvoq) over a computer rendering of inflamed intestines in a transparent body.
NASH Drug Candidate Comes With 'Serious Risks,' Says FDA Staff

Agency reviewers signal little support for first potential nonalcoholic steatohepatitis drug

May 17, 2023
FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with fibrosis.
Safety Data on Maternal RSV Vaccine 'Favorable,' FDA Staff Says

But agency reviewers flag numerical imbalance in premature deliveries

May 16, 2023
FDA ADCOMM maternal RSV vaccine over a computer rendering of respiratory syncytial virus.
Opinion
The Broader Significance of a New Drug for a Rare Form of ALS

The tofersen trial offers hope and lessons for the fight against ALS

May 15, 2023
A photo of a physiotherapist assisting a patient with amyotrophic lateral sclerosis
Duchenne Muscular Dystrophy Treatment Narrowly Captures Support of FDA Advisors

Whether vote means FDA will approve Sarepta's gene therapy remains to be seen

May 13, 2023
FDA ADCOMM delandistrogene moxeparvovec (SRP-9001) over a physical therapist working with child with muscular dystrophy
FDA OKs Hormone-Free Pill for Hot Flashes

First-in-class drug works by blocking the NK3 receptor, which plays role in regulating body temp

May 12, 2023
FDA APPROVED fezolinetant (Veozah) over a photo of a mature woman on a couch fanning herself.
Bill to Study Xylazine Passes House, Advances in Senate

Measure does not address scheduling the drug, which is frequently added to fentanyl

May 12, 2023
A photo of Senator Chuck Schumer holding a photo of a bottle of xylazine.
FDA Updates Warnings on All Stimulants for ADHD, Other Conditions

New language emphasizes potential for misuse, abuse, addiction, and overdose

May 12, 2023
An out-of-focus photo of the back of a medication describing precautions and instructions
FDA Panel Backs Needle-Free Epinephrine for Anaphylaxis

Choice of alternative route with nasal spray outweighs possible risks, panelists say

May 12, 2023
FDA ADCOMM epinephrine nasal spray (neffy) over a photo of a man holding this nasal spray
Multiple Solutions Needed to Fix Drug Supply Chain Problems, Lawmakers Told

Better prediction of shortages and more inspections of foreign plants are critical, experts say

May 11, 2023
A screenshot of Morgan Griffith speaking during this hearing.
FDA Relaxes Blood Donation Rules for Gay and Bisexual Men

New guidance ditches MSM-specific screening questions in effort to expand eligibility

May 11, 2023
A photo of a man looking at his smartphone while donating blood.
FDA OKs First Drug for Agitation in Alzheimer's Dementia

Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole

May 11, 2023
FDA APPROVED brexpiprazole (Rexulti) over a photo of a agitated-looking senior woman.
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