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 ...
Managed Healthcare Executive10d
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 ...
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 ...
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 ...
GlobalData on MSN10d
Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
Natco Pharma gets nod for generic Everolimus tablets
The approval is for the Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS) of ...
Daily4d
Natco Pharma gets approval for Everolimus tablets for Oral Suspension for subependymal giant cell astrocytoma
Hyderabad: NATCO Pharma Limited, an Indian pharmaceutical company, has announced the approval of its Abbreviated New Drug ...
Targeted Oncology5d
FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...