The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
The approval is supported by data from three pivotal clinical trials
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
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
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