Pharmaceutical Technology

MARCH 17, 2023

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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pharmaphorum

OCTOBER 19, 2020

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The post FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies appeared first on. months compared with 4.1

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Adverse Reactions FDA Chemotherapy Labelling 57

pharmaphorum

APRIL 1, 2021

The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

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Adverse Reactions Labelling Chemotherapy FDA 53

pharmaphorum

JANUARY 26, 2022

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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The Checkup by Singlecare

OCTOBER 16, 2023

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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Pharmaceutical Technology

NOVEMBER 9, 2022

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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Chemotherapy FDA Adverse Reactions 52

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy showed 3.2

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FDA Adverse Reactions Chemotherapy Labelling 105