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Anis Fahandej-Sadi

Anis Fahandej-Sadi

Head Editor, TLDR Biotech

The top stories in biotech & pharma, straight to your inbox in only one email.

The good, the bad and the ugly.

FDA approves Vanda’s Bysanti for schizophrenia and bipolar I manic or mixed episodes

FDA approves Vanda’s Bysanti for schizophrenia and bipolar I manic or mixed episodes

On February 20, 2026, the FDA approved Bysanti (milsaperidone) from Vanda Pharmaceuticals (VNDA, Nasdaq) for schizophrenia and for manic or mixed episodes associated with bipolar I disorder in adults.  Vanda describes Bysanti as a new chemical entity atypical antipsychotic that is bioequivalent to iloperidone across the therapeutic dosing spectrum, enabling

FDA approvals - December 2025

FDA approvals - December 2025

The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.

FDA approvals - September 2025

FDA approvals - September 2025

September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.

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