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 ...

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

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

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 ...

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

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 ...