Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say

Andrew Dunn

Senior Biopharma Correspondent

Multiple agency sources said FDA Commissioner Marty Makary was behind a short-lived request last week to reject a rare disease drug application from KalVista Pharmaceuticals …

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Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say

Andrew Dunn

Senior Biopharma Correspondent

Sign up to read this article for free.

RFK Jr. says he did not commit to upholding ACIP roster to secure Cassidy’s backing

RFK Jr. pledges to keep the US at the center of the biotech 'revolution'

Nektar's mid-stage eczema data deliver key win in bid for company turnaround

Former FDA scientist and psychedelics researcher hired as CDER deputy director

Updated: Amgen plans lower, slower MariTide doses for obesity drug’s Phase 3

Digital Twins in GMP Manufacturing: Shaping the Future of CPV with Aizon

Ex­clu­sive: FDA's Makary sought re­jec­tion of KalVista’s drug in an un­usu­al move by com­mis­sion­er, sources say

Andrew Dunn

Senior Biopharma Correspondent

Sign up to read this article for free.

RFK Jr. says he did not com­mit to up­hold­ing ACIP ros­ter to se­cure Cas­sidy’s back­ing

RFK Jr. pledges to keep the US at the cen­ter of the biotech 'rev­o­lu­tion'

Nek­tar's mid-stage eczema da­ta de­liv­er key win in bid for com­pa­ny turn­around

For­mer FDA sci­en­tist and psy­che­delics re­searcher hired as CDER deputy di­rec­tor

Up­dat­ed: Am­gen plans low­er, slow­er Mar­i­Tide dos­es for obe­si­ty drug’s Phase 3

Dig­i­tal Twins in GMP Man­u­fac­tur­ing: Shap­ing the Fu­ture of CPV with Aizon

Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say

RFK Jr. says he did not commit to upholding ACIP roster to secure Cassidy’s backing

RFK Jr. pledges to keep the US at the center of the biotech 'revolution'

Nektar's mid-stage eczema data deliver key win in bid for company turnaround

Former FDA scientist and psychedelics researcher hired as CDER deputy director

Updated: Amgen plans lower, slower MariTide doses for obesity drug’s Phase 3

Digital Twins in GMP Manufacturing: Shaping the Future of CPV with Aizon