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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 ...
(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory ...
The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.
With 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 ...
The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype ...
GSK's NDA for linerixibat, for treating itch in PBC patients, gets FDA review with a decision due in March 2026. Skip to main content. Nasdaq+. Weekly Macro+. Scorecard. Market Activity. U.S ...