News Related to Pylarify

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FDA Clears IND for Novel AML Degrader, Approves Prostate Cancer Imaging Agent, Accepts Skin Cancer Therapy Filing

Jun 15, 2026

The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.

FDA Decisions Expected in March 2026 for Multiple Biotech Drug Candidates

Feb 16, 2026

The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.