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January 08, 2026
Article
The FDA has not approved the sNDA for tasimelteon in jet lag disorder in its current form, citing positive efficacy but limited real-world applicability.
January 07, 2026
Quarter 4 2025 showed robust advancements in the nephrology field, including FDA news, trial updates, and featured content.
The Q4 recap for endocrinology spotlights major FDA decisions, updates to diabetes care standards, and key clinical trial updates.
This updated approval builds on the success of Fibryga’s 2024 approval for AFD, which was based on positive data from the phase 3 FIBRES trial.
The FDA grants priority review of Vera Therapeutics’s Biologics License Application for the B-cell modulating, atacicept, in IgAN.
January 06, 2026
Alixorexton receives FDA Breakthrough Therapy Designation, promising significant advancements in treating narcolepsy type 1.
Catch up with major FDA decisions, critical conference news, and more.
January 05, 2026
Data from the ongoing phase 4 PETITE-T1D study, highlighting the substantially reduced progression to stage 3 T1D, headline the application.
The designation follows positive phase 2b data and FDA alignment on a phase 3 trial.
The decision expands upon caplacizumab’s 2019 approval for adults with acquired thrombotic thrombocytopenic purpura.
