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Remember back in April when a law firm, on behalf of an unnamed pharmaceutical company, filed a citizen petition asking the FDA to reform its public release of CRLs? Turns out that HHS took that complaint pretty seriously, temporarily pausing their release, Zachary Brennan reports.
Here's my question: What was the company? If you know, I'm all ears. |
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Max Bayer |
Senior Reporter, Endpoints News
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by Ryan Cross
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After an infant last year was saved from a deadly diseasethanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in... | |
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by Lei Lei Wu
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After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after... | |
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HHS Secretary Robert F. Kennedy Jr. (Graeme Sloan/Sipa USA via AP Images) |
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by Max Bayer
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A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that... | |
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by Zachary Brennan
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The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The... | |
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by Nicole DeFeudis
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The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released... | |
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