Author: FDAcop

Laboratories across the United States are currently navigating a significant shift due to a new federal rule that extends the Food and Drug Administration’s (FDA) regulatory oversight to lab-developed tests (LDTs). This rule mandates that most tests crafted by individual labs for internal use will now need to comply with FDA requirements for medical devices, […]

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Astellas Pharma has achieved a landmark FDA approval for its new drug, Vyloy, designed to treat a rare form of gastrointestinal cancer targeting the protein claudin 18.2 (CLDN18.2). This approval marks Vyloy as the pioneer in a novel class of oncology drugs aimed specifically at combating gastric or gastroesophageal junction (GEJ) adenocarcinoma. Vyloy, or zolbetuximab, […]

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In February, Boston Scientific initiated a recall for its Obsidio Conformable Embolic device, a product designed to block blood flow in target vessels. This recall was driven by reports of seven injuries and two deaths associated with the product’s use. Originally, the Obsidio device was noted for its capability to act like a liquid under […]

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Sanofi is significantly expanding its involvement in cancer treatment through a substantial equity investment of €300 million into a new venture that focuses on pioneering radioligand therapies. This new initiative will carry on under the branding of Orano Med, a subsidiary affiliated with Orano Group with whom Sanofi has previously collaborated. Notably, Sanofi had licensed […]

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Generative artificial intelligence (AI) is increasingly being harnessed within the pharmaceutical industry to streamline the processing of unstructured data, gain insights, and automate previously labor-intensive tasks. While AI is not a panacea, its versatility is proving to be highly beneficial in numerous pharmaceutical applications. David Latshaw, CEO and co-founder of BioPhy, emphasized the importance of […]

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The 2022 Dobbs decision reversed Roe v. Wade, altering federal abortion protections and enabling states to set their restrictive laws, creating access barriers in conservative regions. About 21.5 million women are affected, facing hurdles like longer travel, increased costs, and complex logistics, hitting low-income and women of color hardest and worsening health disparities. Healthcare providers […]

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CMR Surgical recently celebrated a significant achievement by obtaining FDA authorization for its Versius robotic system, initially approved for gallbladder removal surgeries. This milestone marks the first FDA approval granted through the agency’s de novo pathway for a multi-port, soft tissue general surgical robot. The de novo pathway helps introduce new medical devices into the […]

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Intuitive Surgical has reported significant growth in the third quarter, with revenues reaching $2.04 billion, marking a 17% increase compared to the previous year. The company’s net income also saw a considerable rise, totaling $565.1 million, a 36% year-over-year increase. A major highlight for Intuitive this quarter was the performance of its da Vinci surgical […]

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Gilead Sciences has announced its decision to voluntarily withdraw the cancer drug Trodelvy from the U.S. market as a treatment for advanced urothelial carcinoma. This decision was made almost five months after a confirmatory Phase 3 study showed the drug failed to meet the primary endpoint of overall survival with statistical significance. The withdrawal, decided […]

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At a pivotal moment for the Food and Drug Administration (FDA), Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health (CDRH), addressed an audience at the MedTech Conference in Toronto. Since being appointed as the acting director in July, following Jeff Shuren’s retirement in June after a 15-year tenure, Tarver […]

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