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Omeros seeks urgent FDA meeting after it rejects key drug

Shares in Omeros plummeted yesterday after the FDA rejected approval of its narsoplimab drug for a rare and life-threatening complication of haematopoietic stem cell transplants (HSCT), say

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FDA panel backs booster shot for J&J COVID-19 vaccine

An FDA advisory committee voted unanimously in favour of a booster dose of Johnson & Johnson's one-shot COVID-19 vaccine on Friday, as panellists suggested it should have been used as a

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Califf re-joining FDA would be positive for industry; analys...

With rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden's nomination to be the next FDA commissioner, at least one analyst thinks the appointment w

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Flash FDA approval sends ChemoCentryx spiralling upwards

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor.

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FDA panel backs Takeda's CMV drug for transplant patients

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of

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J&J joins COVID-19 booster shot drive, filing with FDA

Johnson & Johnson's COVID-19 vaccine has been a minor player in the US vaccination drive so far, but the company hopes it can have a bigger role as a booster shot.

Omeros seeks urgent FDA meeting after it rejects key drug

FDA panel backs booster shot for J&J COVID-19 vaccine

Califf re-joining FDA would be positive for industry; analys...

Flash FDA approval sends ChemoCentryx spiralling upwards

FDA panel backs Takeda's CMV drug for transplant patients

J&J joins COVID-19 booster shot drive, filing with FDA

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

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