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Biogen, Sage prep 2022 filing for depression drug zuranolone

The renaissance of Biogen and Sage Therapeutics antidepressant zuranolone continues, with the companies indicating they now plan to start a rolling submission for the drug early next year.<

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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

Biogen, Sage prep 2022 filing for depression drug zuranolone

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

CEPI steps in to fund Moderna's pandemic flu jab

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