Granules India Limited receives final approval from USFDA for its new drug
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and ...
Vanda Pharmaceuticals Files for New Drug Application for Tradipitant for Motion Sickness Treatment
Vanda Pharmaceuticals Inc. recently made a significant move by filing a new drug application for Tradipitant. The application, targeted at addressing motion sickness, was publicized through a social ...
MindMed's LSD Anxiety Drug: Revisiting, Rethinking, But Maintaining My 'Hold' Call
Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.
Business Wire12d
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 ...
JD Supra13d
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 ...
Managed Healthcare Executive7d
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 ...
Cure Today1d
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Vyluma Announces Acceptance of Drug Application for NVK002 by China’s National Medical Products Administration (NMPA)
With its acceptance by the NMPA, NVK002 is now under regulatory review across three major global markets: the United States, the European Union, and China. This milestone reinforces Vyluma’s vision of ...