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GSK PLC (LSE:GSK, NYSE:GSK) shares dropped 6% on Friday, erasing over £3 billion from its market value, after a panel of experts advising the US Food and Drug Administration voted against the company's Blenrep drug combinations for advanced multiple myeloma. The advisory committee concluded that the benefits of Blenrep, also known as belantamab mafodotin-blmf, did not outweigh the risks at the proposed dosage used in clinical trials.
GSK shares fell more than 6% on Friday after a U.S. FDA advisory panel recommended against approving its blood cancer drug Blenrep, citing earlier concerns over eye-related side effects.
An expert panel advising the US drug regulator has voted against GSK PLC's (LSE:GSK, NYSE:GSK) Blenrep drug combinations for patients with relapsed or refractory multiple myeloma. The US Food and Drug Administration's oncologic drugs advisory committee voted against the overall benefit/risk profile of belantamab mafodotin-blmf based on the proposed dosage used in clinical studies.
The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.
The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug Blenrep, when used in combination with other treatments, may cause eye damage in patients.
FDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the use of its respiratory syncytial virus (RSV) vaccine to adults under the age of 50 at a higher risk of the disease.
PHILADELPHIA--(BUSINESS WIRE)--GSK begins shipping influenza vaccine doses for the 2025-26 flu season.
GSK is witnessing increased sales growth of its Specialty Medicines unit, a trend expected to continue through the rest of 2025.