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BioWorld - Wednesday, March 11, 2026
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Home » FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine
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A sleigh full of approvals

FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine

Dec. 23, 2019
By Michael Fitzhugh
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.
BioWorld Regulatory Cancer Neurology/psychiatric FDA

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