FDA Approves VEKLURY (Remdesivir) for Adults and Pediatric Patients for the Treatment of COVID-19 Requiring Hospitalization
FDA Approves PHESGO (Pertuzumab, Trastuzumab and Hyaluronidase-zzxf) in Combination with Chemotherapy for Patients with HER2-Positive Early Breast Cancer, or in Combination with Docetaxel for Patients with HER2-Positive Metastatic Breast Cancer who have not Received Prior Anti-HER2 Therapy or Chemotherapy for Metastatic Disease
FDA Approves INQOVI for Adult Patients with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
FDA Approves RUKOBIA in Combination with Other Antiretroviral(s), for HIV-1 Infection in Heavily Treatment-Experienced Adults with Multidrug-Resistant HIV-1 Infection Failing Their Current Antiretroviral Regimen
BYFAVO for Induction and Maintenance of Procedural Sedation in Adults Undergoing Procedures Lasting 30 Minutes or Less
FINTEPLA for Dravet Syndrome Seizures
ZEPZELCA for Patients with Metastatic Small Cell Lung Cancer on or after Platinum-Based Chemotherapy
Linking In Vitro Antiviral Data to the In Vivo Setting in the Fight Against COVID-19
FDA Approves QINLOCK for Advanced Gastrointestinal Stromal Tumor
FDA Approves TABRECTA (Capmatinib) for Treatment of Adult Patients with Metastatic Non-small Cell Lung Cancer
FDA Approves RETEVMO (Selpercatinib) for the Treatment of Adult Patients with Metastatic RET Fusion-positive Non-small Cell Lung Cancer
FDA Approves TUKYSA (Tucatinib) for use in Combination with Trastuzumab and Capecitabine for Treatment of Adult Patients with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
FDA Approves KOSELUGO for Neurofibromatosis Type 1 who Have Symptomatic, Inoperable Plexiform Neurofibromas
FDA Approves ZEPOSIA (Ozanimod) for the Treatment of Relapsing Forms of Multiple Sclerosis in Adults
FDA Approves SARCLISA (isatuximab-irfc) for the Treatment of Adult Patients with Multiple Myeloma
FDA Announces Availability of Two Final Guidances, Clinical and In Vitro Drug Interaction Studies -- Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions
FDA Approves AYVAKIT (Avapritinib) for the Treatment of Adults with Unresectable or Metastatic Gastrointestinal Stromal Tumor Harboring a Platelet-derived Growth Factor Receptor Alpha Exon 18 Mutation