The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
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 company announced that it has been granted patent covering “Substituted Ethylamine Fused Heterocyclic Mescaline Derivatives.”
The accelerated review covers WCK 5222 for multiple critical infections
The acquisition adds HLD-0915, a once-daily oral therapy for prostate cancer, to Johnson & Johnson’s nearly 20-year legacy of innovation in the disease
The funding will accelerate Sinopia’s data-driven drug discovery efforts
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
Harbour BioMed brings advanced antibody discovery platforms to the table
NGD Infection Prevention was formed to scale the delivery of sequence-based transmission detection
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