The FDA has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for adults and pediatric patients aged 12 years and older with previously untreated stage III or IV...
The FDA has approved icotrokinra, an oral interleukin-23 receptor antagonist, for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or...
On March 3, 2026, the FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg per actuation, for the maintenance treatment of asthma as prophylactic therapy in...
The FDA has approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis, a rare form of chronic sinus inflammation driven by hypersensitivity to fungal organisms in the sinuses, in...
The FDA has authorized a first-of-its-kind therapeutic device that delivers tumor-treating fields for adults with locally advanced pancreatic cancer. The approval offers a new non-invasive option to extend...
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....
