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Original New Drug Application Approvals by US FDA (01 - 15 February 2021)

16 Feb 2021

New drug applications approved by US FDA as of 01-15 February 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (01 - 15 February 2021)

16 Feb 2021

Less aggressive therapy reasonable in primary GI mantle cell lymphoma

15 Feb 2021

Primary gastrointestinal (GI) mantle cell lymphoma (MCL) is a rare disease with distinct presentations as compared to secondary GI MCL, a recent study has found. Patients with the primary malignancy tend to receive less aggressive treatment, but nevertheless achieve comparable clinical outcomes.

Less aggressive therapy reasonable in primary GI mantle cell lymphoma

15 Feb 2021

FOLFOX/XELOX improves survival, response rate in CRC patients with DDR-mutated tumour

13 Feb 2021

Mutations affecting DNA damage response (DDR) are present in 22 percent of patients with metastatic colorectal cancer (CRC), reports a study. Initial treatment with fluoropyrimidine with oxaliplatin (FOLFOX/XELOX) improves overall survival in this population and is associated with a numerically higher response rate than fluoropyrimidine with irinotecan (FOLFIRI).

FOLFOX/XELOX improves survival, response rate in CRC patients with DDR-mutated tumour

13 Feb 2021

Autologous stem cell transplant poses slight second malignancy risk to MM patients

13 Feb 2021

Autologous stem cell transplant (aHSCT) seems to increase the risk of haematologic second primary malignancy (SPM) among multiple myeloma (MM) patients, though the absolute estimates were small, a recent has found.

Autologous stem cell transplant poses slight second malignancy risk to MM patients

13 Feb 2021

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Original New Drug Application Approvals by US FDA (01 - 15 February 2021)

Original New Drug Application Approvals by US FDA (01 - 15 February 2021)

Less aggressive therapy reasonable in primary GI mantle cell lymphoma

Less aggressive therapy reasonable in primary GI mantle cell lymphoma

FOLFOX/XELOX improves survival, response rate in CRC patients with DDR-mutated tumour

FOLFOX/XELOX improves survival, response rate in CRC patients with DDR-mutated tumour

Autologous stem cell transplant poses slight second malignancy risk to MM patients

Autologous stem cell transplant poses slight second malignancy risk to MM patients