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FDA’s Conditional Approval Plan Would Unleash Biotech Innovation

Forbes LogoForbes18h ago

FDA’s Conditional Approval Plan Would Unleash Biotech Innovation - Forbes

Quick Summary:

For patients with ultrarare diseases who currently have no approved treatments, the traditional approach often means waiting indefinitely for therapies that pharmaceutical companies have little incentive to develop.

The traditional approach requires pharmaceutical companies to conduct extensive clinical trials involving hundreds or thousands of patients, randomized to either receive the investigational treatment or a placebo.

The proposed pathway could help level the playing field for rare disease research, potentially leading to breakthroughs for patients who have historically had few treatment options.


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Article Details

Author / Journalist: Greg Licholai MD, Contributor

Category: StartupsTechnology

Markets:

Topics:

Source Website Secure: Yes (HTTPS)

News Sentiment: Neutral

Fact Checked: Legitimate

Article Type: News Report

Published On: 2025-05-05 @ 08:00:00 (18 hours ago)

News Timezone: GMT -5:00

News Source URL: forbes.com

Language: English

Article Length: 966 words

Reading Time: 6 minutes read

Sentences: 46 lines

Sentence Length: 21 words per sentence (average)

Platforms: Desktop Web, Mobile Web, iOS App, Android App

Copyright Owner: © Forbes

News ID: 28397946

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About Forbes

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Main Topics: StartupsTechnology

Official Website: forbes.com

Update Frequency: 55 posts per day

Year Established: 1917

Headquarters: United States

News Last Updated: 12 hours ago

Coverage Areas: United States

Ownership: Independent Company

Publication Timezone: GMT -5:00

Content Availability: Worldwide

News Language: English

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API Access: Available (JSON, REST)

Website Security: Secure (HTTPS)

Publisher ID: #40

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