[ Price : $8.95]
FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or t...[ Price : $8.95]
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.[ Price : $8.95]
The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management mat...[ Price : $8.95]
Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan d...[ Price : $8.95]
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsore...[ Price : $8.95]
FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.[ Price : $8.95]
Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.[ Price : $8.95]
A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.