FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant prostate cancer.
NOxBOX recalls its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the devices manifold.
FDA clears the ReddyPort elbow device used in non-invasive ventilation.
FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility.
Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of the KEYSTONE A-18 cer...
FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer patients.
FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.
The CDER Office of Translational Sciences 2022 annual report lists what it says were achievements in five areas of activity.
