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, ...

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

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 ...

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

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Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (“PRA”), the Securities and Exchange Commission (“Commission”) is submitting to the Office of ...

Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a ...

A person with knowledge of the deal says Oklahoma City Thunder star Shai Gilgeous-Alexander has agreed to a four-year contract extension.