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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.

FDA Panel to Mull Covid Vaccine Strain Selection

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FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on th...

Amicis Research Didnt Follow Investigation Plan: FDA

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FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research...

Trump Administration Seeks Mifepristone Case Dismissal

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The Trump administration asks a federal judge to dismiss a lawsuit filed by three GOP states that seeks to block access to the abo...

More Unannounced Foreign Inspections Coming

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FDA says it is expanding the use of unannounced inspections of foreign medical product and food manufacturing facilities.