Jan 1, 2025 · The FDA decision on Datopotamab Deruxtecan, proposed for the treatment of patients with previously treated metastatic HR-positive, HER2-negative breast cancer, is due on January 29, 2025.

3 days ago · The FDA decision on Supernus Pharma's SPN-830, an investigational apomorphine infusion device for the continuous treatment of motor fluctuations ("OFF" episodes) in Parkinson's disease, is...

Sep 1, 2024 · The FDA is scheduled to determine whether or not to convert accelerated approval of Travere Therapeutics' Filspari to a traditional approval on September 5, 2024.

Jan 1, 2025 · The FDA decision on Datopotamab Deruxtecan, proposed for the treatment of patients with previously treated metastatic HR-positive, HER2-negative breast cancer, is due on January 29, 2025.

Sep 30, 2024 · The FDA decision on Biofrontera's request to increase the maximally approved dosage of Ameluz from one to three tubes per treatment is expected on October 4, 2024.

Dec 2, 2024 · The FDA decision on Datopotamab deruxtecan, proposed for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who have received prior systemic therapy, is due on December 20, 2024.

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Oct 30, 2024 · The FDA decision on Autolus Therapeutics' Obe-cel, proposed for the treatment of patients with relapsed/refractory adult B-cell acute lymphoblastic leukemia, is expected on November 16, 2024.