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Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application drugs
April 18, 2019
Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application.
Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA drugs
April 17, 2019
Cosmo Pharmaceuticals NV informed that the Remimazolam NDA has been submitted to FDA.
FDA Approves Avaclyr for the treatment of herpetic keratitis drugs
April 17, 2019
FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis.
Darolutamide NDA to treat non-metastatic castration-resistant prostate cancer europeanpharmaceuticalreview
April 12, 2019
A New Drug Application has been made to the US Food and Drug Administration for the drug darolutamide to treat non-metastatic prostate cancer…
FDA accepts NDA for Lemborexant to treat Insomnia biospectrumasia
March 12, 2019
The NDA submission was based on data from the clinical development program including two pivotal Phase 3 studies of lemborexant - SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303).
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia pharmafocusasia
March 12, 2019
Eisai Co., Ltd. and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P. (President and CEO: Craig Landau, MD), today announced that the U.S. Food and Drug Administration (FDA) has accepted f
FDA accepts Sarepta’s NDA for precision medicine Golodirsen pharmaceutical-technology
February 18, 2019
US precision medicine company Sarepta Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for its Duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053)....
Recro Pharma Amends IV Meloxicam License Agreement with Alkermes pharmafocusasia
December 24, 2018
Recro Pharma, Inc., a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today announced an amendment to ...
Alkermes, Biogen Submits NDA for Diroximel Fumarate americanpharmaceuticalreview
December 18, 2018
Alkermes and Biogen announced Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098).....
FDA Grants Priority Review for Daiichi Sankyo's NDA for FLT3 Inhibitor Quizartinib americanpharmaceuticalreview
November 29, 2018
Daiichi Sankyo announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment....

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