Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...

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 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 ...

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

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The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.

GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...

Moderna reports that it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax.