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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.

    • Melanie Senior

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  4. 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...

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

    4 janv. 2022 · The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. See the list of new drugs, their sponsors, properties, indications and review status.

    • Asher Mullard
    • new drug application1
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  6. 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;...

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

    10 janv. 2023 · The report showcases FDA's role in bringing safe and effective drug therapies to patients for various diseases and conditions, including COVID-19, cancer, and rare diseases. It also highlights the use of expedited development and review methods, biosimilars, and pediatric approvals.

  8. 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 ...

  1. quotientsciences.com· Supports a cure

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