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
Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories
The agreement, signed in December 2025, grants Takeda an exclusive worldwide license to use Halozyme’s proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) with vedolizumab
The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit
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