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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-November-2025

31 Dec 2025

New drug applications approved by US FDA as of 1-15 November 2025 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-November-2025

31 Dec 2025

Lubiprostone use heightens risk of headache

30 Dec 2025

Treatment with lubiprostone is associated with an increased risk of headache in adults and children, according to a recent meta-analysis.

Lubiprostone use heightens risk of headache

30 Dec 2025

Is there a link between IDA, cow’s milk intake, and bottle feeding?

30 Dec 2025 by

A study from Canada demonstrates the burden of severe iron deficiency anaemia (IDA) among healthy children in the context of ongoing bottle feeding and excessive cow’s milk intake.

Is there a link between IDA, cow’s milk intake, and bottle feeding?

30 Dec 2025

Multikingdom microbial biomarker test for autism risk assessment aids earlier diagnosis & intervention

30 Dec 2025 by

Researchers from the Chinese University of Hong Kong (CUHK) have developed the world’s first artificial intelligence (AI)–powered multikingdom microbial biomarker test for autism spectrum disorder (ASD) risk assessment. By accurately excluding ASD in low-risk cases, the test may facilitate earlier diagnosis and intervention in high-risk groups.

Multikingdom microbial biomarker test for autism risk assessment aids earlier diagnosis & intervention

30 Dec 2025

From nontargeted therapy to CGRP-targeted therapy: Breakthrough in first-line migraine prevention

30 Dec 2025 by

Migraine is a highly disabling neurological condition that profoundly affects patients’ quality of life (QoL) and productivity. Traditional first-line (1L) preventive treatments were not originally developed for migraine and are often limited by suboptimal efficacy and poor tolerability. In an interview with MIMS Doctor, Dr William Kingston of the Division of Neurology, Department of Medicine, Temerty School of Medicine, University of Toronto, Canada, discussed the emergence of calcitonin gene–related peptide (CGRP) inhibitors, including atogepant, as a significant breakthrough in migraine prevention, offering targeted, migraine[1]specific efficacy with improved tolerability.

From nontargeted therapy to CGRP-targeted therapy: Breakthrough in first-line migraine prevention

30 Dec 2025

Mitapivat improves Hb levels in paediatric patients with PK deficiency

30 Dec 2025 by

Treatment with mitapivat increased haemoglobin (Hb) levels in children with pyruvate kinase (PK) deficiency who were not receiving regular blood transfusions, according to the ACTIVATE-Kids trial presented at ASH 2025.

Mitapivat improves Hb levels in paediatric patients with PK deficiency

30 Dec 2025

Bladder preservation possible in select MIBC patients

29 Dec 2025 by

Neoadjuvant chemotherapy (NAC) with transurethral resection (TUR) for bladder preservation is feasible for some patients with muscle-invasive bladder cancer (MIBC) who meet established selection criteria, suggests a study. However, recurrence may occur beyond 10 years, warranting lifetime surveillance.

Bladder preservation possible in select MIBC patients

29 Dec 2025

Subgroup analysis shows durable efficacy, safety of iptacopan for PNH treatment

29 Dec 2025 by

In a subgroup analysis of patients with paroxysmal nocturnal haemoglobinuria (PNH) with a history of aplastic anaemia and concomitant immunosuppressive therapy (AA + IST), long-term treatment with iptacopan yields clinically meaningful improvements in haemoglobin levels, transfusion needs, and haemolysis control, with safety outcomes comparable to those in individuals without AA.

Subgroup analysis shows durable efficacy, safety of iptacopan for PNH treatment

29 Dec 2025

First patient treated with sotatercept for pulmonary arterial hypertension in HK’s public healthcare sector

29 Dec 2025 by

A 35-year-old female civil servant with good past health was admitted to our centre on 28 April 2025 with a 6-month history of shortness of breath on exertion, wheeze, bilateral lower-limb oedema, 3 kg weight gain, and chest pain. She had no constitutional symptoms or palpitations, and no family history of rheumatologic disease or pulmonary arterial hypertension (PAH).

First patient treated with sotatercept for pulmonary arterial hypertension in HK’s public healthcare sector

29 Dec 2025

What is the best intervention for fever-related discomfort in children?

28 Dec 2025 by

In children with fever-associated discomfort, pharmacological interventions appear safe and effective, while physical methods provide limited benefits, suggest the results of a systematic review.

What is the best intervention for fever-related discomfort in children?

28 Dec 2025

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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-November-2025

Original-New-Drug-Application-Approvals-by-US-FDA--1-15-November-2025

Lubiprostone use heightens risk of headache

Lubiprostone use heightens risk of headache

Is there a link between IDA, cow’s milk intake, and bottle feeding?

Is there a link between IDA, cow’s milk intake, and bottle feeding?

Multikingdom microbial biomarker test for autism risk assessment aids earlier diagnosis & intervention

Multikingdom microbial biomarker test for autism risk assessment aids earlier diagnosis & intervention

From nontargeted therapy to CGRP-targeted therapy: Breakthrough in first-line migraine prevention

From nontargeted therapy to CGRP-targeted therapy: Breakthrough in first-line migraine prevention

Mitapivat improves Hb levels in paediatric patients with PK deficiency

Mitapivat improves Hb levels in paediatric patients with PK deficiency

Bladder preservation possible in select MIBC patients

Bladder preservation possible in select MIBC patients

Subgroup analysis shows durable efficacy, safety of iptacopan for PNH treatment

Subgroup analysis shows durable efficacy, safety of iptacopan for PNH treatment

First patient treated with sotatercept for pulmonary arterial hypertension in HK’s public healthcare sector

First patient treated with sotatercept for pulmonary arterial hypertension in HK’s public healthcare sector

What is the best intervention for fever-related discomfort in children?

What is the best intervention for fever-related discomfort in children?