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 portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products
This is also an important milestone in our product strategy for our expansion into the larger Latin American market
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
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