Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Artificial intelligence coupled with laboratory automation will transform how scientific work is performed
BFF provides bookable fermentation upscaling capacity, process expertise, and quality procedures for pilot campaigns, generating decision-grade data without companies needing to build their own facilities
CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function
CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms
Vanda strongly disputes the FDA’s reasoning
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