04/06/2026 Amneal secures FDA nod and 180‑day CGT exclusivity for ready‑to‑use romidepsin injection in cutaneous T‑cell lymphoma Amneal secures FDA nod and 180‑day CGT exclusivity for ready‑to‑use romidepsin injection in cutaneous T‑cell lymphoma (Ref) Amneal received US FDA approval for its romidepsin injection solution (27.5 mg/5.5 mL), supplied in ready-to-use vials Competitive Generic Therapy (CGT): The product qualifies for CGT designation, granting 180 days of market ex

April 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B