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FDA Approves First ALS Drug Since 2017

Some of the agency’s reviewers feel there isn't sufficient evidence to approve the medication.

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A recent New York Times article discussed the approval of a new treatment for A.L.S., a neurological disorder that leads to paralysis and death. However, there are questions pertaining to how effective the drug is as some reviewers believe there isn’t sufficient evidence that it prolongs life or slows the progression of the progressive neuromuscular disease.

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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FDA warning letters surge - is your team prepared?
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
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Pharmaceutical Innovations Report