The FDA approval expands frontline treatment options for adults with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, based on randomized trial data showing...
The FDA has cleared a once-daily oral semaglutide treatment for adults with obesity or overweight and weight-related conditions, based on phase 3 OASIS 4 trial results demonstrating significant mean weight...
The FDA initiated approval of leucovorin calcium tablets to treat cerebral folate deficiency (CFD) following a systematic analysis demonstrating promise in this patient population.
The FDA has announced mandatory labeling changes for all opioid pain medications to more clearly communicate the risks associated with long-term use, including addiction, overdose, and other serious harms....
The FDA announced on June 12 that it has approved pembrolizumab for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1.
The FDA announced the approval of darolutamide for treating metastatic castration-sensitive prostate cancer. This review was conducted under Project Orbis, which allows for concurrent submission and review...
Secretary Robert F. Kennedy Jr. announced that the CDC will no longer recommend the COVID-19 booster vaccine for healthy children and pregnant people. The announcement comes despite previous CDC...
The FDA has announced that it will limit access to COVID-19 vaccines, making them only available to high-risk populations. The organization also announced that they will require manufacturers to further...
The FDA has approved suzetrigine 50 milligram oral tablets for moderate to severe acute pain in adults. The drug acts on the peripheral nervous system before pain signals can reach the brain, eliminating...
The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.
