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Former FDA Staff Chief Joins Hogan Lowells

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Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology pra...

Vertex Signal Inhibitor VX-993 Misses Trial Goal

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Vertex Pharmaceuticals says it will not pursue its investigational VX-993 as monotherapy for acute pain following bunionectomy sur...

Dyne Gets Breakthrough Status for Duchenne Therapy

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FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystroph...

TransMedics Gets Heart Trial Conditional Approval

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FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.

Philips Respironics Recalls Ventilators

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Philips Respironics recalls (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to ...

Anixa Bio Moving Breast Cancer Vaccine Into Phase 2

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Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towar...

Turmoil Led to Pazdur Overriding BLA Decision: Report

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A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur ...

HHS Sean Keveney Named FDA Chief Counsel

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HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.

Novo Nordisk Hemophilia Drug Expanded Approval

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FDA approves Novo Nordisks Alhemo (concizumab-mtci) as a once-daily preventive treatment for bleeding episodes in patients 12 year...

Regeneron Odronextamab BLA Rejected Again

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FDA issues Regeneron a second complete response letter on its BLA for odronextamab and its use in relapsed/refractory follicular l...