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Biocon Publishes Two Phase III Studies Supporting Yesafili FDA Interchangeable Designation
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FDA Finalizes 12-Digit NDC Rule, Setting March 2033 Deadline for Full System Conversion

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Biocon Publishes Two Phase III Studies Supporting Yesafili FDA Interchangeable Designation

Biocon publishes two INSIGHT Phase III studies for Yesafili, covering switch safety and DME subgroup data ahead of U.S. launch.

Pharma Now Editorial Team

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FDA Finalizes 12-Digit NDC Rule, Setting March 2033 Deadline for Full System Conversion

FDA's final rule mandates a uniform 12-digit NDC by March 7, 2033, with a three-year labeling transition and hard enforcement from March 2036.

Pharma Now Editorial Team

Pharma Now

Replimune Faces CTGT Advisory Committee Review of Melanoma BLA on July 30, 2026

FDA's CTGT AdCom will review Replimune's BLA 125827 for vusolimogene oderparepvec on July 30, 2026. Public comment docket closes July 29.

Pharma Now Editorial Team

Pharma Now

Octapharma Gains FDA Supplemental Approval for FIBRYGA Fibrinogen Concentrate in Acquired Deficiency

FDA granted Octapharma a supplemental approval for FIBRYGA on June 23, 2025, expanding its fibrinogen concentrate label to include acquired fibrinogen deficiency.

Pharma Now Editorial Team

Pharma Now