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Sanofi Gains FDA Approval for Subcutaneous Isatuximab-irfc Delivered via CirCLIQ On-Body Device
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AB Science Suspends Three Masitinib Trials to Concentrate Resources on ALS and AML Programs

Vaibhavi M.

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Sanofi Gains FDA Approval for Subcutaneous Isatuximab-irfc Delivered via CirCLIQ On-Body Device

FDA approves Sanofi's subcutaneous isatuximab-irfc via CirCLIQ OBDS for three multiple myeloma indications, raising combination product manufacturing requirements.

Vaibhavi M.

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AB Science Suspends Three Masitinib Trials to Concentrate Resources on ALS and AML Programs

AB Science discontinues three masitinib trials, directing resources to AML and ALS programs amid regulatory closeout and amendment obligations.

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Merck Gains FDA Approval for IV and Subcutaneous Pembrolizumab Each with Enfortumab Vedotin in Muscle Invasive Bladder Cancer

FDA approves Merck's IV and subcutaneous pembrolizumab each with enfortumab vedotin for all MIBC patients eligible for cystectomy.

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India Tightens Controls on High-Alcohol Medicinal Formulations to Curb Misuse

India tightens regulatory controls on high-alcohol medicinal formulations, raising compliance obligations for manufacturers and importers.

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