Q1 2026 Preview: 5 FDA Decisions to Watch in Specialty Care Patrick Campbell

Published Date: 14 Jan 2026

Explore five pivotal FDA decisions set for early 2026 that could transform specialty medicine and enhance treatment options across various conditions.

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Todays Updates

EMA Backs Breast Cancer SERD After FDA No Vote

The recommendation follows phase 3 data showing longer progression-free survival when patients switched to camizestrant plus a CDK4/6 inhibitor.

Datopotamab Deruxtecan Earns New Breast Cancer Indication

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Lupus contributes substantially to premature mortality in young women, with over 304,000 years of potential life lost in women aged 15-44 years from 2000 to 2015.

Pulmonary Fibrosis Video Diaries: Patient Experiences and Timely Diagnosis of IPF

From Evidence to Action: Practical Strategies for FcRn Therapy in gMG

Next-Gen Therapies for gMG: The Science and Support for FcRn Antagonists

Strategies for Personalized CIDP Care: Patient Selection, Treatment Transition, and FcRn Therapy

Transforming CIDP Management: Early Diagnosis, Pathophysiology, and the Emerging Role of FcRn Antagonists

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Phase III results put obinutuzumab in line for approval

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American patients report more symptoms and mostly don't agree with doctors on how they've fared

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Advantage plans do a better job than standalone Part D policies, albeit with important gaps

ICE Chief Hospitalized; Metastatic Colon Cancer at Age 26; TENS for Fibromyalgia

Health news and commentary gathered by MedPage Today staff

Dyspnea in Woman With RA Reveals a Diaphragmatic Lipoma

MRI can help differentiate these benign soft-tissue masses from more aggressive liposarcomas

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Prompt diagnosis of this rare progressive autoimmune disease may help preserve hearing, eyesight

What Caused Left-Sided Hearing Loss in This 65-Year-Old Man?

Numerous diagnostic procedures revealed tophaceous gout affecting the middle ear

EULAR: Docs Should Push Hard on Physical Activity for Arthritis Patients

We have met the enemy and it's the sofa, updated guideline indicates

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Drug Targeting TLRs in Cutaneous Lupus Looks Good in Mid-Stage Studies

— Dose-response signal appears in phase II trial, and all doses are better than placebo

Upadacitinib After TNF Inhibitor Failure Improves RA Control

In patients with active RA, switching to upadacitinib after failure of a single TNF inhibitor is more effective in reducing disease activity at 12 weeks than using a second TNF inhibitor adalimumab.

Early Anti-TNF to Prevent Difficult-to-Treat RA Gains Steam

The availability of TNF inhibitor biosimilars and the cost of treating ‘difficult-to-treat’ RA are making first-line TNF inhibition in early RA more attractive in the UK.

FDA Grants Breakthrough Therapy Designation to Ianalumab, First Potential Sjögren’s Targeted Therapy Victoria Johnson

Novartis plans to submit regulatory applications for ianalumab in early 2026.

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FDA approves a label update for the BEAR implant, which was previously approved in 2020.

FDA Grants Priority Review to Efgartigimod, First Potential Therapy for Seronegative Myasthenia Gravis Victoria Johnson

argenx's efgartigimod-alfa therapy was approved for seropositive generalized myasthenia gravis in 2021.

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