Food and Drug Administration (FDA)
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Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The best thing a professional can do when considering a position at the FDA is weigh the pros and cons. To help, we’ve created a guide to working at the FDA, with benefits, challenges and tips.
On Wednesday, the FDA authorized new Omicron-specific booster shots for Pfizer-BioNTech and Moderna’s COVID-19 vaccines despite a lack of human data.
The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.
Pfizer is to report initial data from a randomized trial of the second course of therapy of paxlovid in COVID-19 rebound patients by Sept. 2023.
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