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Fast Track Awarded to Polycythemia Vera Drug

[ Price : $8.95]

FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic can...

FDA Implementing AI-Assisted Scientific Review

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FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6...

Court Confirms FDA Drug Shortage Ruling was Valid

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A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabe...

SS Innovations Seeks De Novo on Surgical Robot

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SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.

Inspection Disruptions Wont Rise to Covid Level: Expert

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Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not...

Therivas Pancreatic Cancer Drug Hits Endpoints

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Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to t...

Moderna Flu/Covid Vaccine Beats Comparators: Study

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A Moderna Phase 3 study says its combination mRNA flu and Covid-19 vaccine achieved a greater immune response than comparator stan...

Omeros BLA Resubmission for Narsoplimab

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FDA accepts for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated throm...

Bill Would Create FDA Inspector General

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Sen. Eric Schmitt introduces legislation to create an inspector general for FDA and two other public health agencies.

Oncologic Panel to Review 4 Cancer Submissions

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FDA announces a 5/20-21 Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions.