August 07, 2026

FDA Approves Viral Therapy Plus Nivolumab

Accelerated approval is based on objective response rate and duration of response in advanced melanoma, with postapproval trials required to confirm clinical benefit.

MDSpire News

June 30, 2026

FDA Expands Pediatric Roflumilast Use

The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.

MDSpire News

June 29, 2026

FDA Approves Pediatric Risankizumab

Approval expands risankizumab use to pediatric plaque psoriasis and psoriatic arthritis and includes a new 55-mg prefilled syringe for weight-based dosing in patients weighing less than 40 kg.

MDSpire News

June 29, 2026

Where Are Adults Getting Sunburned?

Water-related activities were the most commonly reported setting for recent sunburn, while more than one-half of respondents reported sunscreen use at the time of their most recent sunburn.

MDSpire News

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.

MDSpire News

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.

MDSpire News

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.

MDSpire News

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.

MDSpire News

May 18, 2026

FDA Clears Golimumab Biosimilars

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

MDSpire News

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