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Based on new clinical study data, AbbVie says it will seek accelerated approval for telisotuzumab-vedotin in patients with c-Met p...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Produc...[ Price : $8.95]
UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.[ Price : $8.95]
FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.[ Price : $8.95]
FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.[ 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Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.