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Lillys Mirikizumab Hits Ulcerative Colitis Trial Endpoints

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Lilly says its mirikizumab hit primary and secondary endpoints in the LUCENT-1 ulcerative colitis Phase 3 induction study.

Comments Reopened on Orange Book Listings

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Federal Register notice: FDA reopens the comment period for a 6/1/2020 notice entitled Listing of Patent Information in the Orange...

FDA Withdraws Approval of 19 Not Marketed NDAs

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Federal Register notice : FDA withdraws approval of 19 NDAs from multiple applicants after they notified the agency that the drugs...

Nipride Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Exela Pharma Sciences Nipride RTU (sodium nitroprusside), 10mg/50mL, was not withdraw...

CDRH Publishes 90 Examples of Real-World Evidence Use

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CDRH publishes an analysis of 90 examples of ways in which real-world evidence has been used in regulatory submissions and decisio...

Stakeholders Question HHS Premarket Notification Plan

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Four medical device stakeholders voice objections to a Trump administration HHS plan to declare some medical devices exempt from F...

AbbVie Rinvoq sNDA Review Extended 3 Months

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FDA extends by three months its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patie...

Catalyst OrthoScience Shoulder System Cleared

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FDA clears a Catalyst OrthoScience 510(k) for its reverse shoulder system.

Multilateral Working Group on Pharmaceutical Mergers

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The Federal Trade Commission says it is joining with several other organizations that regulate competition to update the approach ...

Merck NDA for Belzutifan Accepted for Priority Review

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FDA accepts for priority review a Merck NDA for belzutifan for treating patients with von Hippel-Lindau disease-associated renal c...