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
The acquisition of AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m) positions Bayer at the forefront of cardiac amyloidosis diagnostics
AbbVie will offer reduced prices for its medicines in Medicaid and commit $100 billion over the next decade to US research, development and capital investments, including domestic manufacturing
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes
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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