Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, […]readmore
Tags : Agios
Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: […]readmore
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, […]readmore
Shots: Agios to receive ~$1.8B upfront in cash & ~$200M as regulatory milestones for Vorasidenib along with 5% royalties on sales of Tibsovo in the US from transaction close through […]readmore
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to […]readmore
Shots: The FDA’s BT designation is based on MDS arm of P-I dose-escalation and expansion study assessing Tibsovo (500mg) in 12 patients with r/r MDS with a susceptible IDH1 mutation […]readmore