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 ...
Business Wire6d
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 ...
BioSpace1d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Managed Healthcare Executive15h
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 ...
Monthly Prescribing Reference21h
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.
Healio1d
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 ...
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial; U.S. regulatory approval in WHIM syndrome ...
JD Supra6d
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 ...
JD Supra2d
Patent Poetry: Federal Circuit Reverses Novartis Patent Decision
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...
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 ...
FiercePharma2d
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...