The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Bayer announced an FDA review extension for Elinzanetant, its experimental menopausal hot flash therapy. Approval remains on track. REad more here.

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

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 plasma cells, the British drugmaker said on Thursday.

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 new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.

London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

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The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release ...