Results 271 to 280 of about 1,709,620 (289)
Gifted Underachievement and its Dynamic Etiology [PDF]
Perry, Stephanie L.
core +1 more source
An advanced F‐doped and ─CN group co‐modified FCCN is developed. Due to the synergistic effects of co‐modification in promoting photogenerated exciton generation, enhancing charge kinetics, expanding active interfacial areas, and optimizing CO2 interfacial reactions, the FCCN photocatalyst demonstrates excellent catalytic performance and high ...
Sheng‐Qi Guo +9 more
wiley +1 more source
Reconfigurable Magnetic Soft Microrobot for Acoustically Triggered Targeted Bacterial Sterilization
Reconfigurable magnetic soft microrobots integrate in situ‐grown piezoelectric zinc oxide nanorods that produce reactive oxygen species upon acoustic excitation. Combining magnetically guided transport with thermally induced planar reconfiguration, the microrobots achieve targeted delivery and enhanced bacterial sterilization through efficient on ...
Quan Gao +12 more
wiley +1 more source
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The journal of prevention of Alzheimer's disease, 2023
Aducanumab is the first FDA-approved amyloid-lowering immunotherapy for Alzheimer’s disease. There is little real-world data to guide management of amyloid-related imaging abnormalities (ARIA), a potentially serious side-effect which requires ...
Matthew D. Howe +7 more
semanticscholar +1 more source
Aducanumab is the first FDA-approved amyloid-lowering immunotherapy for Alzheimer’s disease. There is little real-world data to guide management of amyloid-related imaging abnormalities (ARIA), a potentially serious side-effect which requires ...
Matthew D. Howe +7 more
semanticscholar +1 more source
Medicare Spending on Drugs With Accelerated Approval
Annals of Internal Medicine, 2022BACKGROUND The U.S. Food and Drug Administration provides accelerated approval to drugs on the basis of surrogate end points deemed to be "reasonably likely" to predict clinical benefit. To receive full approval, drugs must complete a confirmatory trial.
Jeromie Ballreich +6 more
semanticscholar +1 more source
The FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process.
Journal of the American Medical Association (JAMA), 2022This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.
Daniel G Aaron, I. G. Cohen, E. Adashi
semanticscholar +1 more source
Clinical Cancer Research, 2020
On April 22, 2020, the FDA granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY; Immunomedics, Inc.) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for ...
S. Wahby +18 more
semanticscholar +1 more source
On April 22, 2020, the FDA granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY; Immunomedics, Inc.) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for ...
S. Wahby +18 more
semanticscholar +1 more source
Potential policy reforms to strengthen the accelerated approval pathway.
Journal of Comparative Effectiveness Research, 2021The accelerated approval pathway for new drugs in the United States is often praised but faces growing criticism of whether it is finding the appropriate balance between uncertainty, access and cost.
A. Kaltenboeck +2 more
semanticscholar +1 more source
Raising Medicaid Rebates For Drugs With Accelerated Approval.
Health Affairs, 2021Through the Accelerated Approval Program, the Food and Drug Administration (FDA) may approve drugs that treat severe or life-threatening conditions on the basis of preliminary evidence of efficacy. Many of these drugs are made available at extremely high
Benjamin N. Rome, A. Kesselheim
semanticscholar +1 more source
JAMA Oncology, 2018
Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver +11 more
semanticscholar +1 more source
Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver +11 more
semanticscholar +1 more source

