Oculis Successful End-Of-Phase 2 Meeting With The FDA, On Towards Phase 3
Oculis, the Icelandic-Swiss clinical stage boipharmaceutical company recently announced that they are progressing towards Phase 3 with OCS-01 in two
Tag: FDA
Cyclo Therapeutics Reports on Eighteen Month Expanded Access Program in Single Alzheimer’s Patient
Cyclo Therapeutics, Inc., a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C
Az amerikai gyógyszerhatóság (FDA) engedélyezte a ciklodextrinnel formulázott remdesivir használatát COVID-19 kezelésére
A Gilead Sciences, Inc. amerikai gyógyszercég tegnap bejelentette, hogy a U.S. Food and Drug Administration (FDA, amerikai gyógyszerhatóság) úgynevezett “emergency
SBECD-enabled Remdesivir Receives FDA’s Emergency Use Authorization for the Treatment of COVID-19
Gilead Sciences, Inc. yesterday announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for
Hundreds of Virus Patients Allowed to Try Gilead’s Ebola Drug
Hundreds of coronavirus patients have been treated with Gilead’s experimental Ebola treatment under an FDA program to allow access to
Axsome Therapeutics Announces Acceleration of MOMENTUM Phase 3 Trial of AXS-07 in Migraine
Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today
Sage Therapeutics Announces FDA Approval of ZULRESSO™ (SBECD-enabled brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression
Approval based on results from three pivotal trials showing treatment with ZULRESSO provided significant and rapid reduction of depressive symptoms
Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of ZULRESSO™ (brexanolone) Injection for Treatment of Postpartum Depression
If approved, ZULRESSO would be the first medicine specifically indicated for the treatment of postpartum depression (PPD) Sage Therapeutics (NASDAQ:
FDA Approves KYPROLIS® (carfilzomib) In Combination With Dexamethasone For Patients With Relapsed Or Refractory Multiple Myeloma
Amgen (NASDAQ:AMGN) recently announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA)
Amgen Submits Supplemental New Drug Application For KYPROLIS® (carfilzomib)
Amgen announced on the 27th August, 2018 the submission of a supplemental New Drug Application (sNDA) to the U.S. Food