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FDA Approves Dupixent as First and Only Targeted Therapy for Bullous Pemphigoid in the US

The Pharma Data

FDA Approves Dupixent as the First and Only Targeted Therapy for Adults with Bullous Pemphigoid In a groundbreaking development for patients suffering from a rare and debilitating autoimmune skin disease, the U.S. This designation provides certain development incentives, including market exclusivity, tax credits, and fee waivers.

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FDA Approves KEYTRUDA for Neoadjuvant and Adjuvant Treatment of PD-L1+ Resectable Head & Neck Cancer

The Pharma Data

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. Furthermore, regulators in Europe and Japan are evaluating applications for this new regimen.

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Levers for Biological Progress

Codon

Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. In the pursuit of truth, science needs no market; technology, on the other hand, has no reality beyond its application and exists only in relation to the marketplace. It involves pragmatism and cultural sensitivity.

DNA 133
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FDA approves Novartis’ copycat of blockbuster Biogen drug

BioPharma Drive: Drug Pricing

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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CBD Research: A Dive into the Regulations of Cannabis Research

Advarra

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements.

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FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

The Pharma Data

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex. “The