SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary ...
Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already delivered Trial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approval ...
On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for ...
Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...
Earlier this year, researchers at Children's Hospital of Philadelphia and Penn created a first-of-its-kind drug customized to a unique genetic mutation to save an infant named Baby KJ from dying of a ...
FDA discussed a broader indication of "treatment of recently acutely suicidal patients" with Bipolar Depression. This broader indication does not require ketamine as the only stabilization agent. The ...
Penn Medicine and the Children's Hospital of Philadelphia will begin testing a new gene therapy for rare diseases following the release of a new Food and Drug Administration protocol on Nov. 12. Penn ...
There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...
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