Business Wire5d
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 ...
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 ...
JD Supra5d
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 ...
New drug development tool could revolutionize industry
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...
cidrap.umn6d
BARDA to fund development of COVID preventive drug
Shionogi will receive $375 million to develop a long-acting protease inhibitor designed to prevent SARS-CoV-2 infection in ...
Healio8d
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, ...
pulmonologyadvisor2d
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
News Medical on MSN6d
Researchers launch startup to revolutionize targeted drug delivery using milk exosomes
Two Nebraska researchers have launched a startup company aimed at bringing to market an innovative method for delivering therapeutics, gene editing tools, plasmids and more to targeted locations in ...
Nasdaq13d
BioCryst Pharmaceuticals Provides 2025 Revenue Guidance and Pipeline Updates for ORLADEYO and New Drug Applications
Plans for 2025 include a new drug application for ORLADEYO granules for children under 12 and advancements in clinical programs for Netherton syndrome and diabetic macular edema. The company's ...
Zacks.com on MSN1d
J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use
Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for ...