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FDA Clears Path for Regenxbio’s Gene Therapy, Signaling Shift in Rare Disease Regulation

July 1, 2026
The FDA has paved the way for Regenxbio’s gene therapy, marking a significant regulatory development in the treatment of rare diseases. This decision comes as part of the agency’s ongoing efforts to streamline the approval processes for therapies targeting conditions with limited treatment options. The move reflects a growing recognition of the urgent need for…

Incyte Drops Lawsuit as CMS Relents on Classification of Opzelura

July 1, 2026
Incyte has officially withdrawn its lawsuit following a decision by the Centers for Medicare & Medicaid Services (CMS) to not classify its JAK inhibitor cream, Opzelura, as a line extension of Jakafi. This development marks a significant shift in the regulatory landscape for Incyte, which had been seeking clarity on the classification that could impact…

Cytomos’ AuraCyt Digital Predictive Cell Analytics Platform Showcased at BIO Conference

July 1, 2026
Cytomos reports that it is showcasing its flagship cell analytic intelligence platform AuraCyt®, together with its novel Celledonia® benchtop technology, designed to enhance predictive cell analytics. Current challenges in the bioprocessing sector include slow, label-dependent analytical methods that hinder scalability and offer limited predictive insights, according to Cytomos. The AuraCyt platform measures intrinsic cell physics…

Genprex’s Reqorsa combo secures Canadian patent for lung cancer

July 1, 2026
Genprex has received a Notice of Allowance from the Canadian Intellectual Property Office (CIPO) for a patent concerning the use of its Reqorsa gene therapy in combination with PD-1 or PD-L1 antibodies for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). This development marks a significant milestone in the…

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