Original New Drug Application Approvals by US FDA (1-15 March 2026)

New drug applications approved by US FDA as of 1-15 March 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

PYLARIFY TRUVU

• Active Ingredient(s): Piflufolastat F-18
• Strength: 1mCi/mL-120mCi/mL
• Dosage Form(s) / Route(s): Solution;intravenous
• Company: Aphelion
• Approval Date: 6 March 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
• with suspected metastasis who are candidates for initial definitive therapy
• with suspected recurrence based on elevated serum prostatespecific antigen (PSA) level
• Approved Label:  6 March 2026 (PDF)