This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
The inspection concluded with one minor observation in Form 483
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
The approval by the US FDA comes after extensive safety testing and manufacturing improvements
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