Food and Drug Administration (FDA)
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95% of those surveyed agreed that the pandemic showed the vulnerabilities of the medicine supply chain.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.
The FDA sent an email holding the planned Phase I trial for LB1901 after the first and only patient dosed was found to have low CD4+ T-cell counts in the peripheral blood.
The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics’ IV Tramadol.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
Psychedelics therapies – serotonin 2 A receptor agonists – are trying to enter mainstream medicine for depression and as anti-inflammatory or neuroprotective treatments.
After a filibuster was broken Monday, the Senate confirmed Califf’s nomination in a 50-46 bipartisan vote.
Robert Califf’s nomination to resume his role as FDA Commissioner continues to advance in the Senate, despite some opposition from a key Democrat, Sen. Joe Manchin.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
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