Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients
The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing
Backed by two CAP - accredited genomics labs in Delhi NCR and Mumbai, supporting oncology, reproductive health, neurology, transplant immunology, and rare diseases
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
Vanda strongly disputes the FDA’s reasoning
This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway
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