By recent standards, the first quarter of 2024 has been relatively slow in terms of novel drug approvals. Only 10 new drugs were granted authorization in the first three months of the year (Tablel). This compares to 13 in the first quarter of 2023 -a figure that was equalled or best...
1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 2. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2021-biological-license-application-approvals ...
A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
The approval provided a new option for patients with MF and was the first FDA approval of a drug specifically for SS. Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. MF and SS are types of non-Hodgkin lym...
WASHINGTON, Nov. 28 (Xinhua) -- The United States Food and Drug Administration (FDA) approved on Wednesday a new drug, Xospata, for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. ...
"The FDA's approval of Imdelltra marks a pivotal moment for patients battling [extensive-stage small cell lung cancer]," Dr. Jay Bradner, executive vice president of research and development and chief scientific officer at drug maker Amgen, said in a companynews release. "Imdelltra offers th...
NANJING, June 7 (Xinhua) -- China Food and Drug Administration (FDA) has approved the sale of a new drug for the treatment of HIV-1 infection, the maker of the drug said. Aikening, or albuvirtide for injection (ABT), can be used with other antiretroviral drugs to treat infected patie...
FDA New Drug Approval Times,Prescription Drug User Fees and R&D Spending[OL].http://www.aei-brookings,org 2006.John A.Vernon,Joseph H.Golec,Randall Lutter,Clark Nardinelli.“FDA New Drug ApprovalTimes,Prescription Drug User Fees and R&D Spend-ing”.www.aei-brookings.org. 2006...
Before approving a new drug, the Food and Drug Administration (FDA)--an agency of the Department of Health and Human Services (HHS)--assesses a drug's effectiveness. To do so, it examines information contained in a new drug application (NDA), including data from clinical trials in humans....
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