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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...

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.

FDA Ordered to Speed U.S. Drug Manufacturing

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President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.

Vinay Prasad Tapped as New CBER Director

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FDA appoints University of California, San Francisco professor Vinay Prasad to serve as CBERs new director, replacing Peter Marks,...

BIMO Inspection e-Submission Requirements Outlined

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An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to ...

RM Pharma Gains Low-Dose HemiClor Approval

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FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.

Clinical Trials for Covid Boosters: Makary

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FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.