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FDA Releases Corrected Rejection Letter for Corcept NDA

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FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency ha...

Ultragenyx Resubmits BLA for Gene Therapy

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Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfil...

Elevar Submits Lirafugratinib NDA for Bile Duct Cancer

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Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors h...

Sen. Scott Bill to Require Country-of-Origin on Rx Labels

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Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and ...

FDA Updates Device Inspection Program Due to QMSR Move

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FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspec...

Grail Submits Final PMA Module for Cancer Blood Test

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Grail files the final module of its PMA for the companys multi-cancer early detection blood test.

Biogen Breakthrough Status for Lupus Therapy

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FDA awards Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythe...

Senators Question HHS Oversight of TrumpRx Platform

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A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription ...

FDA Approves Yuvezzi Combination Eye Drop for Presbyopia

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FDA approves Tenpoint Therapeutics Yuvezzi as the only combination eye drop approved to treat presbyopia in adults.

Agency Clarifies Clinical Decision Support Software

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FDA posts an updated guidance clarifying when clinical decision support software functions fall outside the definition of a regula...