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Original New Drug Application Approvals by US FDA (16 - 30 November 2022)

05 Dec 2022

New drug applications approved by US FDA as of 16 - 30 November 2022 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 (16 - 30 November 2022)

05 Dec 2022

MELTUMP, SAMPUS rarely lead to metastatic malignancies

03 Dec 2022

There appears to be low to no metastatic potential for melanocytic tumours of uncertain malignant potential (MELTUMP) and superficial atypical melanocytic proliferations of uncertain significance (SAMPUS), a recent study has found.

MELTUMP, SAMPUS rarely lead to metastatic malignancies

03 Dec 2022

Colorectal polyps more common in sporadic ampullary adenoma

03 Dec 2022

Patients with sporadic ampullary tumours more commonly have colorectal polyps or neoplasia than healthy controls, a recent study has found.

Colorectal polyps more common in sporadic ampullary adenoma

03 Dec 2022

First-line serplulimab + chemo ups survival in extensive-stage SCLC

02 Dec 2022 by

The addition of serplulimab to chemotherapy in the first-line setting improved overall survival (OS) in patients with extensive-stage small cell lung cancer (SCLC), according to results of the ASTRUM-005 trial.

First-line serplulimab + chemo ups survival in extensive-stage SCLC

02 Dec 2022

Pharmacogenomic profiling of paediatric AML informs precision medicine

02 Dec 2022 by

A study by the Chinese University of Hong Kong (CUHK) has found age-specific differences in drug responses and new gene-drug interactions in paediatric acute myeloid leukaemia (AML).

Pharmacogenomic profiling of paediatric AML informs precision medicine

02 Dec 2022

Esophagogastric junction biopsy may be forgone after endoscopic eradication of BE

02 Dec 2022

Random histological sampling from the esophagogastric junction (EGJ) appears to hold low clinical relevance in patients who have undergone successful endoscopic eradication of all visible Barrett’s esophagus (BE), given that the incidence of intestinal metaplasia at the EGJ does not pose a higher risk of disease recurrence, according to a study.

Esophagogastric junction biopsy may be forgone after endoscopic eradication of BE

02 Dec 2022

The Emerging Role of Biosimilars in Value-Based Medicine

01 Dec 2022

Biologic medicines and biosimilars
Biologic medicines are a category of very specific, highly effective medicines produced by a sophisticated and complex process involving living system¹. Most of them are very large, complex molecules or mixtures of molecules, and many are produced using recombinant DNA technology. These medicines have revolutionised the treatment and prevention of many disabling and life-threatening diseases including cancers, Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, osteoporosis, psoriasis, human immunodeficiency virus, multiple sclerosis, growth deficiencies, and more¹.

The Emerging Role of Biosimilars in Value-Based Medicine

01 Dec 2022

Pituitary TF–based classification improves diagnostic accuracy and prognostication of nonfunctioning PitNETs

30 Nov 2022 by

Utility of pituitary transcription factors (TFs) improves the diagnostic accuracy and prognostication of nonfunctioning pituitary neuroendocrine tumours (NF-PitNETs), according to local data and a new diagnostic classification presented at the 5^th Annual Meeting of Endocrinology, Diabetes & Metabolism Hong Kong (EDM HK).

Pituitary TF–based classification improves diagnostic accuracy and prognostication of nonfunctioning PitNETs

30 Nov 2022

FRESCO-2: Fruquintinib improves OS in heavily pretreated mCRC

30 Nov 2022 by

Fruquintinib, a highly selective and potent oral tyrosine kinase inhibitor of VEGFR*-1, -2, and -3, significantly improves overall survival (OS) in heavily pretreated patients with metastatic colorectal cancer (mCRC), according to the FRESCO-2** trial presented at ESMO 2022.

FRESCO-2: Fruquintinib improves OS in heavily pretreated mCRC

30 Nov 2022

Married HCC patients have better overall survival

28 Nov 2022

Among hepatocellular carcinoma (HCC) patients, being married appears to have positive prognostic implications on overall survival (OS), a recent study has found.

Married HCC patients have better overall survival

28 Nov 2022

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Original New Drug Application Approvals by US FDA (16 - 30 November 2022)

Original New Drug Application Approvals by US FDA (16 - 30 November 2022)

MELTUMP, SAMPUS rarely lead to metastatic malignancies

MELTUMP, SAMPUS rarely lead to metastatic malignancies

Colorectal polyps more common in sporadic ampullary adenoma

Colorectal polyps more common in sporadic ampullary adenoma

First-line serplulimab + chemo ups survival in extensive-stage SCLC

First-line serplulimab + chemo ups survival in extensive-stage SCLC

Pharmacogenomic profiling of paediatric AML informs precision medicine

Pharmacogenomic profiling of paediatric AML informs precision medicine

Esophagogastric junction biopsy may be forgone after endoscopic eradication of BE

Esophagogastric junction biopsy may be forgone after endoscopic eradication of BE

The Emerging Role of Biosimilars in Value-Based Medicine

The Emerging Role of Biosimilars in Value-Based Medicine

Pituitary TF–based classification improves diagnostic accuracy and prognostication of nonfunctioning PitNETs

Pituitary TF–based classification improves diagnostic accuracy and prognostication of nonfunctioning PitNETs

FRESCO-2: Fruquintinib improves OS in heavily pretreated mCRC

FRESCO-2: Fruquintinib improves OS in heavily pretreated mCRC

Married HCC patients have better overall survival

Married HCC patients have better overall survival