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Guide on Sterility Info in 510(k) Submissions

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FDA revises its guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions fo...

Alcons Positive Dry Eye Phase 3 Trials

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Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy an...

Priority Review Voucher for Adzynma Approval

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Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare ...

Priority Voucher Awarded to Amryt Pharma

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Federal Register notice: FDA announces the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare p...

Sellas Life Sciences Gets Fast Track

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FDA grants Sellas Life Sciences a fast track designation for SLS009, a highly selective CDK9 inhibitor for treating relapsed/refra...

Searchable FDA Pharmaceutical Quality Repository

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FDA launches a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources.

CRL for Astellas Zolbetuximab BLA

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FDA says it cant approve Astellas zolbetuximab BLA by the 1/12 PDUFA action date due to unresolved issues at a third-party manufac...

CAR T-Cell Benefits Outweigh Risks: Marks

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CBER director Peter Marks says there is a positive risk/benefit assessment for CAR-T therapy for its approved uses.

Jungman to be Califf Chief of Staff

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CDER director Patrizia Cavazzoni says ORP director Elizabeth Jungman will become FDA commissioner Robert Califfs chief of staff.

Potential Chemical Exposure in GE Compressors

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FDA cautions that there is the potential for elevated levels of formaldehyde being released when two GE HealthCare compressors are...