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FDA approves new Bristol Myers drug for lung cancer

BioPharma Drive: Drug Pricing

Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.

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Topical Gel for Erectile Dysfunction Gets FDA Approval for Over-the-Counter Sale

Drugs.com

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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Topical Gel for Erectile Dysfunction, Eroxon, Gets FDA Approval for Over-the-Counter Sale

Drugs.com

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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FDA Approves Marketing of Nicotine Pouches

Drugs.com

Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. FRIDAY, Jan. 17, 2025 -- Following an extensive scientific review, the U.S. Nicotine pouches -- small synthetic fiber pouches containing nicotine -- are.

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FDA Approves Label Updates for Bristol Myers Squibb Cell Therapies, Removes REMS

The Pharma Data

FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.

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Challenges in Clinical Development of Products for Rare Disease

thought leadership

There are over 7,000 rare diseases affecting more than 30 million people in the United States, and despite the FDA's approval of over 600 treatments for rare diseases since signing the Orphan Drug Act into law in 1983, most rare diseases still do not have a treatment.