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  3. Pharmaceutical Companies
  4. Axsome Therapeutics
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August 01, 2022

US FDA approval tracker: July 2022

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July 28, 2022

Go or no go? J&J’s bispecific FDA first

Pdufa decisions also beckon for Amicus, Acadia and Bluebird.

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July 04, 2022

US FDA approval tracker: June 2022

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July 01, 2022

Go or no go? FDA firsts for Imfinzi, Enhertu and roflumilast

Assets in oncology and psoriasis are set for upcoming Pdufa decisions.

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June 01, 2022

US FDA approval tracker: May 2022

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May 31, 2022

Go or no go? The FDA’s Amylyx dilemma

June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.

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May 04, 2022

US FDA approval tracker: April 2022

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April 29, 2022

Go or no go? Lilly’s valuable diabetes contender

Tirzepatide heads for its first FDA approval and Enhertu eyes an earlier setting, as Verrica and Axsome keep their fingers crossed.

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April 25, 2022

A second trip-up makes Axsome look careless

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April 01, 2022

Go or no go? Bristol's first-in-class hopes

April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.

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January 05, 2022

US FDA approval tracker: December 2021

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