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14 NovPDUFA: MYQORZO (symptomatic obstructive HCM (based on MAPLE-HCM, vs. metoprolol))14 NovPDUFA: ivonescimab (EGFR-mutated locally advanced or metastatic non-squamous NSCLC after prior EGFR TKI therapy (with chemotherapy))14 NovPDUFA: IGALMI (acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting)19 NovFDA AdComm: Microbiology Devices Panel of the Medical Devices Advisory Committee22 NovPDUFA: Deramiocel (Duchenne muscular dystrophy (DMD))27 NovPDUFA: neladalkib (ALK-positive non-small cell lung cancer)27 NovPDUFA: BBP-418 (limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9))30 NovPDUFA: povetacicept (IgA nephropathy (IgAN), accelerated approval)30 NovPDUFA: bezuclastinib (Gastrointestinal Stromal Tumors (GIST))30 NovPDUFA: Povetacicept (immunoglobulin A nephropathy (IgAN) in adults, accelerated approval)12 DecPDUFA: Quimilza (Generalized Pustular Psoriasis (GPP))12 DecPDUFA: imsidolimab (Generalized Pustular Psoriasis (GPP))14 NovPDUFA: MYQORZO (symptomatic obstructive HCM (based on MAPLE-HCM, vs. metoprolol))14 NovPDUFA: ivonescimab (EGFR-mutated locally advanced or metastatic non-squamous NSCLC after prior EGFR TKI therapy (with chemotherapy))14 NovPDUFA: IGALMI (acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting)19 NovFDA AdComm: Microbiology Devices Panel of the Medical Devices Advisory Committee22 NovPDUFA: Deramiocel (Duchenne muscular dystrophy (DMD))27 NovPDUFA: neladalkib (ALK-positive non-small cell lung cancer)27 NovPDUFA: BBP-418 (limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9))30 NovPDUFA: povetacicept (IgA nephropathy (IgAN), accelerated approval)30 NovPDUFA: bezuclastinib (Gastrointestinal Stromal Tumors (GIST))30 NovPDUFA: Povetacicept (immunoglobulin A nephropathy (IgAN) in adults, accelerated approval)12 DecPDUFA: Quimilza (Generalized Pustular Psoriasis (GPP))12 DecPDUFA: imsidolimab (Generalized Pustular Psoriasis (GPP))

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