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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Business Wire8d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Managed Healthcare Executive2d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
JD Supra8d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Healio4d
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Monthly Prescribing Reference3d
FDA Extends Review of Elamipretide for Barth Syndrome
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
Healio11d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
Morningstar9d
Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of ...
Morningstar5d
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on ...