FDA Announces Draft Guidance Low Frequency Molecular Subsets FDA Approves PREVYMIS (Letermovir) FDA Approves CALQUENCE (Acalabrutinib) FDA Announces Availability of Two Draft Guidances FDA Approves Tracleer® (Bosentan) FDA Approves VABOMERE™ (Meropenem and Vaborbactam) FDA Approves BESPONSA (Inotuzumab Ozogamicin) FDA Uses Extrapolation to Expand FYCOMPA® (Perampanel) FDA Approves MAVYRET (Glecaprevir and Pibrentasvir) FDA Approves VYXEOS® (Daunorubicin and Cytarabine) FDA Approves VOSEVI (Sofosbuvir, Velpatasvir, and Voxilaprevir) FDA Approves RITUXAN HYCELA™ (Rituximab and Hyaluronidase) FDA Approves IDHIFA® (Enasidenib) FDA Issues Highlights of Prescribing Information for BAXDELA™ FDA Approves Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] FDA Expands Kalydeco (Ivacaftor) FDA Approves IMFINZI™ (Durvalumab) FDA Approves RYDAPT® (Midostaurin) FDA Approves DUPIXENT (Dupilumab) FDA Approves OCREVUS (Ocrelizumab) FDA Approves ALUNBRIG (Brigatinib) FDA Approves ZEJULA (niraparib) FDA Approves BAVENCIO (avelumab) FDA Approves KISQALI(ribociclib) FDA Approves SPINRAZA FDA Announces Availability of the Guidance, "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product" FDA Approves RUBRACA™ FDA Announces Availability of the Draft Guidance,"Physiologically Based Pharmacokinetic Analyses-Format and Content"