GlobalData on MSN6d
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 Wire13d
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 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 ...
Morningstar4d
Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a ...
BioSpace8d
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 ...
GlobalData on MSN6d
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.
Morningstar9d
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 ...
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 ...
thecardiologyadvisor.com2d
FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Vanda Pharmaceuticals seeks FDA nod for motion sickness drug
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post ...