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 ...
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 ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Managed Healthcare Executive19h
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 ...
Healio9d
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, ...
ophthalmologytimes13d
FDA accepts revised supplemental New Drug Application for IZERVAY
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
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 ...
Yahoo Finance25d
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...
Targeted Oncology15d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.
Cure Today20d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ...
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 ...