2023 Forecast: FDA Renews Most Cancer Drug Approvals, Big Pharma Leaning To Line Up

In what should be a turning point in the FDA's cancer drug exercise, GSK gained extended recognition for more than one myeloma drug

Blenrep, at the FDA's request, just 15 days after disclosing the failure. of a confirmatory test. The approval contemplated a broader makeover that would occur in the FDA's

An emphasis on multiplied approval suggestions as part of an "evolving regulatory environment within the US." was the key driver behind GSK's decision 

“Big Pharma is doing the right thing,” Daina Graybosch, Ph.D., an analyst at SVB Securities, said in another interview. "That's it. We had an agreement

However, modifications can be difficult for biotech, especially small ones, Graybosch said.

The "deal" Graybosch was aiming for became a stipulation that a drug allowed under the multiple approval pathway using a surrogate endpoint 

In what should be a turning point in the FDA's cancer drug exercise, GSK gained extended recognition for more than one myeloma drug

In what should be a turning point in the FDA's cancer drug exercise, GSK gained extended recognition for more than one myeloma drug

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