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Lebrikizumab Wins FDA Approval for Eczema

38% of patients treated with IL-13 blocker achieved clear or almost-clear skin at 16 weeks

Sep 13, 2024
FDA APPROVED lebrikizumab (Ebglyss) over a photo of a woman with a severe atomic dermatitis rash on her face.
Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says

Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis

Sep 13, 2024
FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with the biliary tree highlighted.
FDA OKs Software to Convert Apple AirPods Into Hearing Aids

Designed for certain models, software can customize audio parameters

Sep 12, 2024
A photo of a woman holding Apple AirPods Pro.
FDA Warning on Hot Flash Drug

Clinicians should perform liver blood tests before and during Veozah treatment

Sep 12, 2024
FDA WARNING fezolinetant (Veozah) over a photo of Veozah tablet, bottle and packaging.
FDA Expands Approval of IL-23 Drug to Ulcerative Colitis

In trials, guselkumab more than doubled remission rates versus placebo

Sep 12, 2024
FDA approved guselkumab (Tremfya) over a computer rendering of ulcerative colitis.
FDA Reviewers Skeptical of Ocaliva for Rare Bile Duct Disease

Agency advisory panel to examine complicated efficacy data and liver safety concerns

Sep 11, 2024
FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with the biliary tree highlighted.
Go After the Big E-Cigarette Makers, Not Vape Shops, House Members Tell FDA

Lawmakers also queried officials about a menthol cigarette rule and labeling of milk alternatives

Sep 10, 2024
A screenshot of Brian King, PhD, speaking during this hearing.
FDA Advisors Question Potential Role of Novel Oral UTI Antibiotic

Concerns about patient selection, antibiotic resistance dominated the discussion

Sep 10, 2024
FDA ADCOMM sulopenem etzadroxil/probenecid (sulopenem) over a computer rendering of bacteria spilling from a bladder.
Experts Want FDA to Do More to Ensure Food Safety

New food ingredients are a "complete black box," one expert says

Sep 09, 2024
A photo of the ingredient list on food product packaging.
FDA Reviewers Voice Concerns Over Novel UTI Treatment

Oral antibiotic has potential for inappropriate use, agency says

Sep 06, 2024
 FDA ADCOMM sulopenem etzadroxil/probenecid (sulopenem) over a computer rendering of bacteria spilling from a bladder.
Opinion
Diversity Action Plans for Clinical Trials: Evaluating FDA's Draft Guidance

A critical analysis reveals opportunities and challenges prior to finalization

Sep 06, 2024
A photo of FDA headquarters in Silver Spring Maryland.
Nurse Goes Missing; Mpox on Airplanes; Warning on Pain Supplements

Health news and commentary gathered by 鶹ý staff

Sep 06, 2024
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.
Teen Vaping Hits 10-Year Low in the U.S.

Rate fell to under 6% this year, down from 7.7% in 2023

Sep 05, 2024
A photo of an Elf Bar and Esco Bar flavored disposable vaping devices.
Nearly 2,000 Pharmaceutical Plants Are Overdue for FDA Checks After COVID Delays

AP finds inspections are lacking nationally and abroad

Sep 05, 2024
A photo collage of newspaper scraps and photos.
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