BioSpace16h
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 ...
Healio13h
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
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 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 ...
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 ...
ophthalmologytimes11d
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.
cidrap.umn5d
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 ...
pulmonologyadvisor1d
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.
EurekAlert!2d
New process for polarity inversion of chemical compounds for precise drug synthesis
Researchers at Leipzig University have developed a new process for reversing the polarity of chemical compounds, also known as umpolung, for the precise synthesis of pharmaceuticals. This innovative ...
Nasdaq12d
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 ...
NPR5d
Medicare targets 15 more drugs for price negotiations — including Ozempic
Those new prices go into effect in January 2026. For the second group of drugs, discussions between the federal government and manufacturers will take up most of 2025. "Once again, we have a ...