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GSK, food and drug administration

Reuters on MSN · 1d

GSK falls as blood cancer drug likely headed for US rejection

(Reuters) -GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended against approving its blood cancer drug Blenrep, citing earlier concerns over side effects.

Medical Dialogues · 2h

GSK fails to gain FDA advisers backing for cancer therapy

GSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of

Financial Times · 1d

GSK blood cancer drug fails to win backing of key US regulatory panel

GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its approval in doubt and sending shares in the pharmaceutical group 7 per cent lower on Friday morning.

Fierce Pharma2d

FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more

In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...

GlobalData on MSN1d

FDA approves GSK’s prefilled syringe presentation of Shingrix

Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.

2don MSN

US FDA approves pre-filled version of GSK's shingles vaccine

The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...

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