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  1. www.fda.gov › drugs › types-applicationsNew Drug Application (NDA) | FDA

    The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the...

  2. www.nature.com › articles › s41587/024/02166-7Fresh from the biotech pipeline: record-breaking FDA ... - Nature

    26 févr. 2024 · Nature Biotechnology - New drug approvals reached an all-time high in 2023, with five gene therapies, the first CRISPR–Cas9-edited therapy and a disease-modifying Alzheimer’s drug.

  3. www.fda.gov › drugs › how-drugs-are-developed-andTypes of Applications | FDA - U.S. Food and Drug Administration

    An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate...

  4. www.nature.com › articles › d41573/022/00001-92021 FDA approvals - Nature

    4 janv. 2022 · Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). See Table 1 for new approvals...

  5. www.nature.com › articles › s41392/024/01770-yTargeted drug approvals in 2023: breakthroughs by the FDA and ...

    20 févr. 2024 · Notably, domestic innovation is flourishing, with five first-in-class drugs, including Glumetinib, a c-Met inhibitor from Haihe Biopharma; Leritrelvir, a 3CL protease inhibitor from Raynovent;...

  6. www.fda.gov › drugs › new-drugs-fda-cders-newNew Drug Therapy Approvals 2022 | FDA

    10 janv. 2023 · In 2022, CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biological products under Biologics License...

  7. www.nytimes.com › 2024/06/17 › businessHow A.I. Is Revolutionizing Drug Development - The New York Times

    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 ...