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

15 Oct 2021

New drug applications approved by US FDA as of 01-15 October 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.

15 Oct 2021

Baricitinib: A potential treatment for alopecia areata?

14 Oct 2021 by

Baricitinib, an oral, selective Janus kinase (JAK)1/JAK2 inhibitor, may help improve hair growth in patients with severe alopecia areata, according to results from the phase III BRAVE-AA1 and BRAVE-AA2 trials.

14 Oct 2021

Syngeneic HSCT confers higher relapse rates, lower nonrelapse mortality in AML patients

14 Oct 2021

Though relapse tends to be higher with syngeneic haematopoietic stem cell transplantation (HSCT), it confers lower rates of nonrelapse mortality, making such procedure a viable alternative treatment option for acute myeloid leukaemia (AML) patients in first complete remission, a recent study has found.

14 Oct 2021

Abnormal nighttime BP doubles death risk in diabetes patients

14 Oct 2021 by

For adults with diabetes, increased blood pressure (BP) at night (reverse dipping) was associated with more than double the risk of death compared with those whose BP dipped as expected at night, according to the longitudinal CHAMP1ON study presented at Hypertension 2021.

14 Oct 2021

Second-line selective internal radiotherapy slows colorectal liver metastases progression

14 Oct 2021 by

Administering a device-based selective internal radiation therapy, in addition to systemic treatment in the second-line setting, extends time to progression in colorectal liver metastases patients, as shown in the phase III EPOCH trial.

14 Oct 2021

Second bDMARD after failure of non-TNFi biologic in RA shows modest drug survival, response

14 Oct 2021

A recent study has shown modest drug survival and primary response of a second biologic disease-modifying antirheumatic drug (bDMARD) in patients with rheumatoid arthritis (RA) switching due to failure of a nontumour necrosis factor inhibitor (non-TNFi) bDMARD as the first agent.

14 Oct 2021

Minimally invasive cardiac surgery on par with median sternotomy in low-risk Asian patients

14 Oct 2021 by

A single-centre study in Singapore has demonstrated the safety and efficacy of minimally invasive cardiac surgery (MICS), producing better outcomes than conventional median sternotomy (MS) procedures in certain respects.

14 Oct 2021

Smoking reduces effect of methotrexate-based treatment in RA patients

14 Oct 2021

Current smoking reduces the response of patients with early rheumatoid arthritis (RA) to methotrexate (MTX) in a dose-responsive manner, regardless of concomitant prednisone use, a recent study has found.

14 Oct 2021

Lenzilumab reduces likelihood of survival without ventilation in COVID-19 patients

14 Oct 2021 by

In hospitalized COVID-19 patients, treatment with the novel GM-CSF* neutralizing monoclonal antibody lenzilumab led to a significant improvement in survival without invasive mechanical ventilation (SWOV), findings from the phase III LIVE-AIR study suggest.

14 Oct 2021

Wearable EMG detects poststroke muscle contractions in inactive patients

14 Oct 2021 by

Wearable surface electromyograpghy (EMG) sensors can detect arm muscle activity in stroke survivors during standard acute care even if no such activity was observed during traditional clinical examination, according to a recent study.

14 Oct 2021

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

Baricitinib: A potential treatment for alopecia areata?

Syngeneic HSCT confers higher relapse rates, lower nonrelapse mortality in AML patients

Abnormal nighttime BP doubles death risk in diabetes patients

Second-line selective internal radiotherapy slows colorectal liver metastases progression

Second bDMARD after failure of non-TNFi biologic in RA shows modest drug survival, response

Minimally invasive cardiac surgery on par with median sternotomy in low-risk Asian patients

Smoking reduces effect of methotrexate-based treatment in RA patients

Lenzilumab reduces likelihood of survival without ventilation in COVID-19 patients

Wearable EMG detects poststroke muscle contractions in inactive patients