Tivdak (tisotumab vedotin-tftv) Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 9/20/2021 4/29/2024 Elahere (mirvetuximab soravtansine-gynx) Adult […]
On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent […]
2024 2023 2022 2021 2020 2019 Understanding the Change Log Welcome to the Quarterly IID Change Log. FDA publishes the IID on a quarterly basis. The […]
The 2023 OND Annual report captures the office’s achievements, including notable drug approvals, guidances, publications, and staff’s involvement in public meetings, workshops, webinars, and conferences. This […]
(Reuters) – Health insurance plans run by U.S. states must cover gender-affirming surgeries for transgender people, a U.S. appeals court ruled on Monday. The 8-6 opinion […]
Several times a year the Center for Drug Evaluation and Research sends out an update to share information on new developments, opportunities, and initiatives in regulatory […]
The Role of Scientific Consortia in Drug Development Background Information The Critical Path Initiative (CPI), and the Strategic Plan for Advancing Regulatory Science Initiative seek to […]
(Reuters) -The U.S. Food and Drug Administration’s website showed on Monday one dose of Novo Nordisk’s weight-loss drug Wegovy as available after being in short supply, […]
TOPLINE: Immune checkpoint inhibitors (ICIs) are now widely used immunotherapies for many cancers, but their use in pregnancy is discouraged because of the lack of safety […]
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