July 29, 2024
About FDA Guidances Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any […]
July 29, 2024
Docket Number: FDA-2021-D-1128 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for […]
July 29, 2024
Sridhar Mantha, M.B.A., M.S., B.Tech.Director, Office of Strategic Programs Sridhar (Sri) Mantha, M.B.A., M.S., B.Tech., serves as Director of CDER’s Office of Strategic Programs (OSP). OSP […]
July 29, 2024
AstraZeneca was taken to task last week by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency […]
July 29, 2024
MUSIC: IN Narrator: Unused medicines can spell many things. RISK, if they’re taken by someone they weren’t prescribed for. HARM, if accidentally taken by a child […]
July 29, 2024
The first HIV cure case in which the stem cell donor had a single — rather than double — gene mutation is opening the donor pool […]
July 29, 2024
On This Page Date: November 15, 2024 Time: 9:00 AM – 5:00 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]
July 29, 2024
Benralizumab, an anti–interleukin-5 receptor alpha monoclonal antibody, was significantly better than placebo at producing a histologic response of up to six eosinophils per high-power field (eos/hpf) […]
July 29, 2024
As disease-modifying treatments for Alzheimer’s disease (AD) become available, equipping primary care physicians with a highly accurate blood test could significantly reduce diagnostic wait times. Currently, […]
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