FDA Bursts

In cooperation with the Food and Drug Administration (FDA), and as a service to our members, we will periodically distribute information about newly approved therapies or significant changes to approved therapies. This helps FDA to inform professionals in patient care arena of recent approvals in a timely manner. Included in the email from the FDA is a link to the product label, which will provide the relevant clinical pharmacology information on the indication, contraindications, dosing, and safety. In sending this information, we do not endorse any product or therapy and do not take any position on the safety or efficacy of the product or therapy described.

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

2019 FDA Bursts

2018 FDA Bursts

2017 FDA Bursts

2016 FDA Bursts