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...
With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels o...
作者: 美国新药获批。 US FDA Novel Drug Approvals for 2024. 美国新药获批。🔗: 网页链接
FDA approvalsDrug developmentMedical productMedicinesEconomic cycleSchumpeterIt is challenging to elucidate the effects of changes in external influences (such as economic or policy) on the rate of US drug approvals. Here, a novel approach—termed the Chronological Hurst Exponent (CHE)—is proposed,...
Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older Related Post:Insights+: The US FDA New Drug Approvals in September 2020...
SHANGHAI, June 27, 2024 /PRNewswire/ -- US FDA New Drug Application Approval of Ohtuvayre™ (ensifentrine) for the Maintenance Treatment of COPD
“We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA,” said Certara’s CEO Dr. William Feehery. “Certara’s Simcyp, Phoenix and Global Submit software platforms have been widely used by both the FDA and the biopharmaceutical ind...
/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA)...
摘要: The article discusses new drugs, new indications and dosage forms as well as new drug/biologics license applications filed by the manufacturer and safety-related changes in labeling or use approved by the U.S. FDA from May 16 through June 15, 2012....
Medical device approvals in the period of 2010 to 2014 were searched from USFDA website. Disease burden data in the similar period was searched from centers for disease control and prevention website. Collected data was analyzed to know number of approved devices, top therapy areas, and ...