GSK plc GSK reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), which beat the Zacks ...

Shares of GSK fell to below $30 around the time of the demerger, but have since recovered to about $36. The 20% gain over 34 ...

The Food and Drug Administration (FDA) has extended the review period for elinzanetant, an investigational hormone-free therapy for the treatment of moderate to severe vasomotor symptoms (VMS) due to ...

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

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

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 ...

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

These changes will have knock-on impacts far beyond US borders, because regulators in many other countries expedite review of FDA-approved drugs.

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending ...