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STAT1h
Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
India Today on MSN7d
US FDA rejects GSK's blood cancer drug over safety, limited treatment benefit
GSK's attempt to relaunch Blenrep was blocked by FDA advisers due to poor clinical benefit, safety concerns, and eye-related ...
Fierce Pharma1d
FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
FDA rejects overall benefit/risk profile of GSK's blood cancer drug dosage
Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...
Zacks Investment Research on MSN6d
FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
GSK says US FDA extends review period for Blenrep BLA until October
(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 ...
BioSpace1d
GSK’s Comeback for Blenrep on Pause as FDA Delays Decision
The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
Nasdaq6mon
FDA Grants Breakthrough Therapy Designation For GSK's GSK'227 ... - Nasdaq
(RTTNews) - GSK plc (GSK), a pharmaceutical and biotechnology company, on Tuesday announced that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation for GSK ...