[ Price : $8.95]
FDA publishes three guidances describing the effect on the review clock and goals of agency and industry actions in de novo, 510(k...[ Price : $8.95]
FDA grants Calithera Biosciences a fast track designation for mTORC 1/2 inhibitor sapanisertib (CB-228) for treating certain adult...[ Price : $8.95]
FDA posts a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.[ Price : $8.95]
FDA releases a final guidance entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.[ Price : $8.95]
FDA grants approval for a Taiho Oncology NDA for Lytgobi (futibatinib) for treating certain adult patients with bile duct cancer.[ Price : $8.95]
FDA sends India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4.[ Price : $8.95]
FDA expands CDERs NextGen Portal to enable certain electronic over-the-counter monograph submissions under section 505G of the Fed...[ Price : $8.95]
FDA adds important information to the emergency authorization of AstraZenecas Evusheld to inform health care providers and individ...