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Second phase 3 trial extends Astellas' lead in claudin 18.2 ...

Astellas has confirmed it is out in front among developers of drugs targeting claudin 18.2, after a second phase 3 trial of zolbetuximab hit its objectives.

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FDA adcomm votes down Cytokinetics heart failure drug

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.

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RSV vaccine race in balance as FDA sets May date for Pfizer ...

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.

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FDA rejects Spectrum's lung cancer drug poziotinib

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

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GSK will pull Blenrep from US market after failed trial

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

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FDA blocks early filing for ADC drug, signalling tougher sta...

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

Second phase 3 trial extends Astellas' lead in claudin 18.2 ...

FDA adcomm votes down Cytokinetics heart failure drug

RSV vaccine race in balance as FDA sets May date for Pfizer ...

FDA rejects Spectrum's lung cancer drug poziotinib

GSK will pull Blenrep from US market after failed trial

FDA blocks early filing for ADC drug, signalling tougher sta...

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