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  1. 17 juin 2024 · How A.I. Is Revolutionizing Drug Development. In high-tech labs, workers are generating data to train A.I. algorithms to design better medicine, faster. But the transformation is just getting ...

  2. Il y a 23 heures · Applications are now closed, but previously, interested parties could propose a project that included conducting clinical trials . Any organization could apply, with an initial aim of a project being to obtain approval for an investigational new drug (IND) application, which is required before clinical trials can begin. NCATS selected projects ...

  3. Il y a 23 heures · The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with PTSD. 1

  4. 18 juin 2024 · The process of bringing a generic drug to market is intricate and highly regulated. The Abbreviated New Drug Application (ANDA) is the primary pathway through which generic drug manufacturers seek approval from the U.S. Food and Drug Administration (FDA).

  5. Il y a 8 heures · Image Credits: Bryce Durbin / TechCrunch. Formation Bio, a startup focused on applying AI to drug development with backing from OpenAI CEO Sam Altman, has raised over a quarter-billion dollars to ...

  6. 4 juin 2024 · A new co-formulated tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) has been developed to aid administration for younger children. The new pediatric tablets are scored to facilitate breaking for ease of swallowing.

  7. 10 juin 2024 · AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT).