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Since the 1962 Kefauver–Harris Amendment, new drugs are statutorily required to demonstrate both safety and effectiveness through substantial evidence for approval. The amendment defines substantial evidence as "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Results from a mid-stage trial published last year in the New England Journal of Medicine showed that tumors shrank in 40% of patients receiving 10 mg of tarlatamab by intravenous infusion every ...
On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications. These INDs ...
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials; Accelerated approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit.
The drug, an antibody-drug conjugate (ADC), was being studied in a trial sponsored by China-based MediLink, in patients with types of non-small cell lung cancer or breast cancer who have received ...