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Original New Drug Application Approvals by US FDA (01-15 December 2023)

18 Dec 2023

New drug applications approved by US FDA as of 01-15 December 2023 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 December 2023)

18 Dec 2023

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

18 Dec 2023 by

A screening programme that incorporates artificial intelligence (AI)-guided digital stethoscope improves clinicians’ ability to detect peripartum cardiomyopathy in the Nigerian SPEC-AI trial.

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

18 Dec 2023

$Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma$

Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma

17 Dec 2023

The investigational selective JAK1 tyrosine-kinase inhibitor golidocitinib demonstrates a favourable benefit–risk profile in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, according to the phase II JACKPOT8 Part B study.

Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma

17 Dec 2023

Albuminuria reduction accounts for treatment effect on CKD outcomes in T2D

17 Dec 2023

Early albuminuria reduction with finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is responsible for a huge proportion of the treatment effect against CKD progression and facilitates a modest amount of the effect against cardiovascular outcomes, reports a study.

Albuminuria reduction accounts for treatment effect on CKD outcomes in T2D

17 Dec 2023

Remimazolam shows promise in procedural sedation

17 Dec 2023

Procedural sedation with remimazolam delivers effective sedation without adversely affecting haemodynamics and respirations or lingering drowsiness, as reported in a study.

Remimazolam shows promise in procedural sedation

17 Dec 2023

Long-term voxelotor use increases Hb, reduces haemolysis markers in patients with SCD

17 Dec 2023 by

Long-term treatment with voxelotor 1,500 mg led to sustained improvements in haemoglobin (Hb) levels and reductions in clinical markers of haemolysis among patients with sickle cell disease (SCD), according to an updated interim analysis of the HOPE open-label extension (OLE) study presented at ASH 2023.

Long-term voxelotor use increases Hb, reduces haemolysis markers in patients with SCD

17 Dec 2023

Weight loss with tirzepatide reversed after stopping treatment

16 Dec 2023 by

For individuals with overweight or obesity who are taking tirzepatide for weight management, continued treatment results in sustained and even augmented weight loss. When treatment is stopped, however, the achieved weight loss is substantially reversed.

Weight loss with tirzepatide reversed after stopping treatment

16 Dec 2023

Antiplatelet therapy de-escalation a promising strategy for East Asian patients undergoing PCI

15 Dec 2023

De-escalation of antiplatelet therapy appears to yield more favourable outcomes compared with standard dual antiplatelet therapy (DAPT) in East Asian patients with acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI), as shown in a study.

Antiplatelet therapy de-escalation a promising strategy for East Asian patients undergoing PCI

15 Dec 2023

Getting both COVID-19 and flu shots at once just as effective as separate vaccinations

15 Dec 2023 by

Coadministration of the BNT162b2 BA.4/5 bivalent mRNA COVID-19 vaccine (BNT162b2-biv) and the seasonal influenza vaccine (SIV) offers protection against the two infections, with an efficacy that is similar as when giving each vaccine alone, according to a study.

Getting both COVID-19 and flu shots at once just as effective as separate vaccinations

15 Dec 2023

Baricitinib, ivermectin, favipiravir rank high among COVID-19 oral antivirals

15 Dec 2023 by

Baricitinib, ivermectin, and favipiravir stood out in terms of efficacy in a network meta-analysis evaluating various novel oral antivirals for the treatment of COVID-19.

Baricitinib, ivermectin, favipiravir rank high among COVID-19 oral antivirals

15 Dec 2023

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Original New Drug Application Approvals by US FDA (01-15 December 2023)

Original New Drug Application Approvals by US FDA (01-15 December 2023)

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma

Golidocitinib shows promise in relapsed or refractory peripheral T-cell lymphoma

Albuminuria reduction accounts for treatment effect on CKD outcomes in T2D

Albuminuria reduction accounts for treatment effect on CKD outcomes in T2D

Remimazolam shows promise in procedural sedation

Remimazolam shows promise in procedural sedation

Long-term voxelotor use increases Hb, reduces haemolysis markers in patients with SCD

Long-term voxelotor use increases Hb, reduces haemolysis markers in patients with SCD

Weight loss with tirzepatide reversed after stopping treatment

Weight loss with tirzepatide reversed after stopping treatment

Antiplatelet therapy de-escalation a promising strategy for East Asian patients undergoing PCI

Antiplatelet therapy de-escalation a promising strategy for East Asian patients undergoing PCI

Getting both COVID-19 and flu shots at once just as effective as separate vaccinations

Getting both COVID-19 and flu shots at once just as effective as separate vaccinations

Baricitinib, ivermectin, favipiravir rank high among COVID-19 oral antivirals

Baricitinib, ivermectin, favipiravir rank high among COVID-19 oral antivirals