Food and Drug Administration (FDA)
NEWS
Although October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.
In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.
AstraZeneca’s Phase III COVID-19 vaccine study in the United States is being further delayed due to the U.S. FDA wanting to take a more thorough look at information related to the trial.
The trial was initially placed on hold in November 2019 due to safety concerns.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
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