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Original New Drug Application Approvals by US FDA (1-15 January 2026)

30 Jan 2026

New drug applications approved by US FDA as of 1-15 January 2026 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 (1-15 January 2026)

30 Jan 2026

AI enhances diagnostic accuracy of mammograms

29 Jan 2026 by

A Singapore study shows that incorporating artificial intelligence (AI) into mammography can improve breast cancer detection rates.

AI enhances diagnostic accuracy of mammograms

29 Jan 2026

HK data: Durvalumab consolidation post-CRT improves PFS in stage III unresectable NSCLC

29 Jan 2026 by

Durvalumab consolidation therapy following concurrent chemoradiotherapy (CRT) extends median progression-free survival (mPFS) in Hong Kong patients with unresectable stage III non-small-cell lung cancer (NSCLC), and also demonstrates a manageable safety profile, according to a real-world study at the Department of Oncology, Princess Margaret Hospital (PMH) conducted by Associate Consultant Dr Sheona Leung, Consultant Dr Fiona Lim, and Associate Consultant Dr Tracy Lau.

HK data: Durvalumab consolidation post-CRT improves PFS in stage III unresectable NSCLC

29 Jan 2026

Expanding adjuvant therapy with ribociclib in HR-positive, HER2-negative early breast cancer

29 Jan 2026 by

Despite advances in adjuvant endocrine therapy (ET), residual recurrence risk remains in patients with hormone receptor (HR)–positive, HER2-negative early breast cancer (eBC). At an industry-sponsored meeting, Professor Michael Untch of the Helios Klinikum Berlin-Buch in Berlin, Germany, and a panel of experts from Hong Kong discussed the survival benefits associated with adding ribociclib, an oral cyclin-dependent kinase (CDK) 4/6 inhibitor, to adjuvant ET in this patient population, and its implications in daily clinical practice.

Expanding adjuvant therapy with ribociclib in HR-positive, HER2-negative early breast cancer

29 Jan 2026

IBD with primary sclerosing cholangitis linked to increased risk of CRC

27 Jan 2026

Patients with inflammatory bowel disease (IBD) face an increased risk of colorectal cancer (CRC), and this association is especially pronounced for those who have primary sclerosing cholangitis (PSC), according to a study.

IBD with primary sclerosing cholangitis linked to increased risk of CRC

27 Jan 2026

Is dairy a health food or a health risk?

26 Jan 2026 by

Consumption of dairy products does not appear to increase the risk of noncommunicable diseases or mortality, according to a scoping review of systematic reviews and meta-analyses.

Is dairy a health food or a health risk?

26 Jan 2026

Body weight predicts dose reduction, discontinuation in HCC patients taking lenvatinib

26 Jan 2026

Patients with hepatocellular carcinoma (HCC) weighing <55 kg who initiate a full dose of lenvatinib tend to lose weight or discontinue treatment, reports a study.

Body weight predicts dose reduction, discontinuation in HCC patients taking lenvatinib

26 Jan 2026

SGLT2 inhibitors may keep ADT working longer in prostate cancer

23 Jan 2026 by

In prostate cancer patients receiving androgen deprivation therapy (ADT), concurrent use of SGLT2 inhibitors appears to delay hormone therapy failure.

SGLT2 inhibitors may keep ADT working longer in prostate cancer

23 Jan 2026

HPV genotyping enhances risk stratification of cervical samples

22 Jan 2026 by

A comprehensive human papillomavirus (HPV) genotyping in combination with cytology improves risk stratification of cervical samples and patient management, suggests a Singapore study.

HPV genotyping enhances risk stratification of cervical samples

22 Jan 2026

FLAURA2 regimen achieves median OS of nearly 4 years in EGFR-mutated advanced NSCLC

22 Jan 2026 by

First-line osimertinib plus chemotherapy demonstrated a median overall survival (mOS) of nearly 4 years in patients with EGFR-mutated (exon 19 deletion or L858R mutation) advanced non-small-cell lung cancer (NSCLC) in the final OS analysis of the FLAURA 2 trial.

FLAURA2 regimen achieves median OS of nearly 4 years in EGFR-mutated advanced NSCLC

22 Jan 2026

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Original New Drug Application Approvals by US FDA (1-15 January 2026)

Original New Drug Application Approvals by US FDA (1-15 January 2026)

AI enhances diagnostic accuracy of mammograms

AI enhances diagnostic accuracy of mammograms

HK data: Durvalumab consolidation post-CRT improves PFS in stage III unresectable NSCLC

HK data: Durvalumab consolidation post-CRT improves PFS in stage III unresectable NSCLC

Expanding adjuvant therapy with ribociclib in HR-positive, HER2-negative early breast cancer

Expanding adjuvant therapy with ribociclib in HR-positive, HER2-negative early breast cancer

IBD with primary sclerosing cholangitis linked to increased risk of CRC

IBD with primary sclerosing cholangitis linked to increased risk of CRC

Is dairy a health food or a health risk?

Is dairy a health food or a health risk?

Body weight predicts dose reduction, discontinuation in HCC patients taking lenvatinib

Body weight predicts dose reduction, discontinuation in HCC patients taking lenvatinib

SGLT2 inhibitors may keep ADT working longer in prostate cancer

SGLT2 inhibitors may keep ADT working longer in prostate cancer

HPV genotyping enhances risk stratification of cervical samples

HPV genotyping enhances risk stratification of cervical samples

FLAURA2 regimen achieves median OS of nearly 4 years in EGFR-mutated advanced NSCLC

FLAURA2 regimen achieves median OS of nearly 4 years in EGFR-mutated advanced NSCLC