May 20, 2025

FDA Releases Guidance to Accelerate Generic Drugs

The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."

Conexiant

May 20, 2025

Clinical Trials Missing in Half of AI Tools

Researchers analyzed FDA-approved AI-enabled medical devices and reported that clinical performance and subgroup data were frequently missing.

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May 16, 2025

FDA Clears First Blood Test for Alzheimer’s

The FDA has cleared the first blood-based test to aid in diagnosing Alzheimer’s disease, offering a less invasive alternative to positron emission tomography scans and cerebrospinal fluid testing for cognitively impaired patients.

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May 15, 2025

First Migraine DHE Autoinjector FDA-Approved

FDA approves Brekiya®, a dihydroergotamine mesylate autoinjector for the acute treatment of migraine with or without aura and cluster headaches in adults.

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May 15, 2025

Chikungunya Vaccine Linked to Adverse Events

The FDA and CDC have paused use of the Ixchiq chikungunya vaccine in adults aged 60 and older due to reports of serious postmarketing adverse events.

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May 05, 2025

FDA Monthly Round-up: Key April Updates

April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.

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May 01, 2025

FDA Approves Intranasal DHE for Acute Migraine Relief

The FDA has approved Atzumi for the acute treatment of migraine with or without aura in adults.

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April 30, 2025

FDA Approves FcRn Blocker for Broad gMG Use

The first FcRn blocker for both adult and pediatric generalized myasthenia gravis has been approved by the FDA, based on data showing sustained symptom improvement and IgG reduction in clinical trials.

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April 29, 2025

New Oral Option Approved for GCA

The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.

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