AVR anteris technologies global corp.

Just a little bit more and I will stop posting on the FDA -"In...

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    Just a little bit more and I will stop posting on the FDA -

    "In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date.

    GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease (COPD) on Wednesday, but the May 7 deadline has come and gone without a decision from the U.S. regulator."

    "This isn’t the first time—or even the second—that the FDA has missed a decision target date this year.

    Early last month, the agency missed its April 1 target date to weigh in on a full approval for Novavax’s protein-based COVID-19 vaccine. Novavax confirmed in an email that the FDA had missed its deadline, noting that it had “responded to all of the FDA’s information requests” and felt that its shot was ready for approval."

 
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