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FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation

Drug Topics

Check out important updates from the FDA for the week of September 30.

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FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics

Drug Topics

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

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FDA Grants Yuflyma Interchangeability Designation for Humira

Drug Topics

The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.

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FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

Drug Topics

Altuviiio was first granted approval by the FDA in February 2023.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity

Drug Topics

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

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FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia

Drug Topics

The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.

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