The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...

The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be ...

Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

The biosimilar will be available in both subcutaneous and intravenous formulations and has nearly all the same indications as ...

The FDA has granted a 510 (k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read). The Ibex Prostate ...

Dr. Tycel Phillips discusses the implications of the FDA approval of Calquence plus bendamustine and Rituxan in untreated MCL ...

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.