An FDA advisory committee has voted against approval of Cytokinetics' cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough.
The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023.
The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea's Hanmi Pharma, which origi
GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US
ADC Therapeutics has said it will not seek accelerated approval of its Hodgkin lymphoma drug camidanlumab tesirine (cami) based on phase 2 results, as the FDA will not review it unless a co
Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote.
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