Drug Approval | December 23, 2025
FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Full approval will depend on verification of clinical benefit in a confirmatory trial
Full approval will depend on verification of clinical benefit in a confirmatory trial
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized
Biocon will be responsible for supplying Semaglutide to Ajanta for exclusive marketing in 23 countries and semi-exclusive marketing in 3 countries across Africa, Middle East and Central Asia
NUFYMCO BLA has been approved by the USFDA
Healthcare and insurance are not parallel systems; they are interdependent pillars of patient trust
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
Xeureka will receive an upfront payment from UBE and will be eligible for milestone payments tied to future research progress
The company also reported significant progress toward its internally defined Sustainable Development Goals
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