The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

(Alliance News) - GSK PLC on Thursday said its Blenrep blood cancer treatment has been approved in Europe, as it awaits a final decision from the US regulator. The London-based pharmaceutical firm ...

The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...

The gene therapy developer is cutting 30% of its workforce. Elsewhere, Abivax secured a major cash infusion, while Novartis and Eli Lilly struck small research deals.

And other biotech news brought to you by The Readout.

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.

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 was trying to revive a product pulled from US markets in 2022. Its shares fell 4.6 per cent, or 65p, to 1348p.

An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...

The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...