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FDA approves Regeneron’s Libtayo and chemotherapy combination for NSCLC

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial.

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FDA approves AbbVie-Genmab’s Epkinly to treat DLBCL

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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Gilead’s Trodelvy approved in metastatic urothelial cancer

pharmaphorum

Gilead’s Trodelvy has another string to its bow after FDA approval in patients with advanced metastatic urothelial cancer. . Trodelvy (sacituzumab govitecan) has been approved for locally advanced or metastatic urothelial cancer, following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor immunotherapy.

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US FDA approves Novartis’ Tafinlar and Mekinist combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Novartis ’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib), to treat BRAF V600E low-grade glioma (LGG) in paediatric patients as young as one year.

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FDA slaps hold on trials of Gilead’s CD47 drug magrolimab

pharmaphorum

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 The post FDA slaps hold on trials of Gilead’s CD47 drug magrolimab appeared first on. billion acquisition of Forty Seven in 2020.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Bridging therapy has been shown to correlate with an inferior response to CAR T-cell therapy due to both progression of the chemotherapy-refractory malignant disease during the manufacturing period and increased toxicity. After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions.

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Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. Cymbalta may have several off-label uses in addition to its FDA-approved uses. It is also approved for fibromyalgia and chronic muscle pain. Approved by the U.S.

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