Food and Drug Administration (FDA)
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Roche’s candidate drug for Alzheimer’s treatment received breakthrough therapy designation which has increased its chance of getting full FDA approval.
If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.
The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.
Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.
Allogene placed its study on hold after sending a notification to the U.S. FDA about a chromosomal abnormality in its ALPHA2 study patient.
Here’s a look at mRNA vaccines and their effectiveness and more COVID-19 news.
Pfizer’s exec team is hit with a double whammy as another c-suite leader announces his retirement.
Retrotope cited data from its Phase II/III trial of RT001 in patients with infantile neuroaxonal dystrophy and reported on a natural history study of INAD patients’ disease onset and progression.
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