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 ...

The combinations are also approved for relapsed or refractory multiple myeloma in Japan, the UK and other markets including Switzerland and Canada.

(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 ...

GSK (GSK) stock in focus as the company secures EU approval for Blenrep combo therapies targeting the blood cancer multiple ...

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

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

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.

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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.