Food and Drug Administration (FDA)
NEWS
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
The COVID-19 pandemic and the virus that causes it, SARS-CoV-2, has been resilient, unpredictable and confounding from the very beginning.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
It was noted early in the COVID-19 pandemic that the disease was peculiar — not only was it a respiratory disease, but it created hyper-immune responses.
The FDA asked Homology Medicines to modify the pheNIX gene therapy trial’s risk mitigation measures to prevent any serious issues that may arise.
Two-plus years into the pandemic, it’s obvious that COVID-19 isn’t going away, prompting discussion about what this “new normal” will actually look like.
Patient enrollment for the clinical trial, which was testing Atara’s autologous chimeric antigen receptor (CAR) T-cell immunology therapy called ATA2271, has been paused.
Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
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