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FDA & Government News

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June 11, 2026

When Bad Data Enters the Drug Pipeline

Federal prosecutors allege that a Florida physician and research staff fabricated clinical trial records that were submitted into database systems used to evaluate investigational drugs.

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June 10, 2026

FDA Approves Less Frequent Lebrikizumab Dosing

Approval adds an every-8-week maintenance option for eligible patients with moderate-to-severe atopic dermatitis.

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June 09, 2026

FDA Permits New Sunscreen Ingredient After 20 Years

The sunscreen ingredient, which has been marketed internationally for years, is considered generally recognized as safe and effective for use in adults and pediatric patients aged 6 months and older.

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May 29, 2026

FDA Expands Guselkumab Label in PsA

Phase 3b APEX findings support the addition of structural joint damage inhibition data to the prescribing information.

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May 18, 2026

FDA Clears Golimumab Biosimilars

New biosimilars enter the market with pharmacy-level substitution eligibility for rheumatology and gastroenterology indications.

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Daily News

Stay up to date with the latest clinical headlines and other information tailored to your specialty.

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May 15, 2026

Why FDA Said No to a Melanoma Drug

Questions over trial design and political pressure shadowed the rejection of Replimune’s RP1 treatment.

Kff Health News

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April 28, 2026

FDA Clears Self-Administered Lupus Therapy

Once-weekly autoinjector approval was based on Phase 3 data, with safety consistent with intravenous administration.

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April 24, 2026

Dupilumab Gains Pediatric CSU Approval

Targets type 2 inflammation in a population with limited treatment options

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April 10, 2026

Injectable Targets Décolleté Wrinkles

New indication expands use of injectable biostimulator beyond the face.

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April 02, 2026

CDC Lists Dozens of Infectious Disease Tests as Unavailable

More than two dozen assays paused or discontinued, with alternative testing options noted

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