Drug Approval | January 05, 2026
FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Shonan iPark was chosen for its globally connected life-science ecosystem, which unites pharmaceutical firms, next-generation medicine developers, AI and digital health innovators, venture capital, and academia
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized
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