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
Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing
The acquisition combines Firstsource’s market-leading AI and automation capabilities with TeleMedik’s operational footprint in Puerto Rico
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function
The integration unifies brand and field strategy, drives executional alignment, and delivers immediate impact measurement
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
The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
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