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London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...
FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
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The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...
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FDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related ItchWith the FDA accepting the NDA for review, a decision from the regulatory body is expected on March 24, 2026. If approved, linerixibat could address an area of high unmet medical need for patients ...
While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 ...
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