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Original New Drug Application Approvals by US FDA (1-15 December 2025)

03 Sep 2026

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

03 Sep 2026

Original New Drug Application Approvals by US FDA (16-31 July 2026)

02 Sep 2026

New drug applications approved by US FDA as of 16-31 July 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 (16-31 July 2026)

02 Sep 2026

Atrial Fibrillation AF AF-related stroke Apixaban Direct Oral Anticoagulants Novel Oral Anticoagulants Anticoagulation NOAC DOAC NOACs DOACs

31 Aug 2026

Atrial fibrillation affects over 52 million people globally, with annual ischemic stroke risk in Asian populations reaching 3.0%, and 11% in Manila.^1-3

Atrial Fibrillation AF AF-related stroke Apixaban Direct Oral Anticoagulants Novel Oral Anticoagulants Anticoagulation NOAC DOAC NOACs DOACs

31 Aug 2026

When to resume antithrombotic therapy after GIB?

31 Aug 2026 by

Early resumption of antiplatelet therapy (APT) and anticoagulant therapy (ACT) ≤7 days after gastrointestinal bleeding (GIB) offers a favourable benefit–risk balance in patients with cardiovascular (CV) or cerebrovascular indications, according to a systematic review and meta-analysis conducted by researchers from the Chinese University of Hong Kong and Nanyang Technological University in Singapore.

When to resume antithrombotic therapy after GIB?

31 Aug 2026

Women with PMOS at high risk of ASCVD

31 Aug 2026

The risk of atherosclerotic cardiovascular disease (ASCVD) events increases by more than fourfold in the presence of polyendocrine metabolic ovarian syndrome (PMOS), according to a retrospective study from the US.

Women with PMOS at high risk of ASCVD

31 Aug 2026

Coronary artery calcium guides statin use eligibility

28 Aug 2026

A recent study suggests the clinical value of coronary artery calcium (CAC) when statin treatment decisions are uncertain, especially among individuals with borderline predicted risk.

Coronary artery calcium guides statin use eligibility

28 Aug 2026

DASH diet may protect against heart failure

25 Aug 2026

Individuals with greater adherence to The Dietary Approaches to Stop Hypertension (DASH) diet have reduced risks of heart failure (HF) and HF-related death, as suggested in a study.

DASH diet may protect against heart failure

25 Aug 2026

Product Highlight - Rivaroxaban (Xafariv)

25 Aug 2026

Film-coated tablet 15 mg and 20 mg

Product Highlight - Rivaroxaban (Xafariv)

25 Aug 2026

Exercise protective against stroke, death in individuals with or without AF

21 Aug 2026

Physical activity helps lower the risks of stroke and mortality, regardless of the presence of atrial fibrillation (AF), according to the Norwegian population-based Tromsø and HUNT studies.

Exercise protective against stroke, death in individuals with or without AF

21 Aug 2026

Mental disorders carry increased long-term mortality risk for patients with permanent pacemakers

20 Aug 2026

For patients with permanent pacemakers, newly diagnosed mental disorders are associated with elevated risk of long-term mortality, according to a study. The association is especially pronounced among younger men and those with early-onset mental disorders.

Mental disorders carry increased long-term mortality risk for patients with permanent pacemakers

20 Aug 2026

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Original New Drug Application Approvals by US FDA (1-15 December 2025)

Original New Drug Application Approvals by US FDA (1-15 December 2025)

Original New Drug Application Approvals by US FDA (16-31 July 2026)

Original New Drug Application Approvals by US FDA (16-31 July 2026)

Atrial Fibrillation AF AF-related stroke Apixaban Direct Oral Anticoagulants Novel Oral Anticoagulants Anticoagulation NOAC DOAC NOACs DOACs

Atrial Fibrillation AF AF-related stroke Apixaban Direct Oral Anticoagulants Novel Oral Anticoagulants Anticoagulation NOAC DOAC NOACs DOACs

When to resume antithrombotic therapy after GIB?

When to resume antithrombotic therapy after GIB?

Women with PMOS at high risk of ASCVD

Women with PMOS at high risk of ASCVD

Coronary artery calcium guides statin use eligibility

Coronary artery calcium guides statin use eligibility

DASH diet may protect against heart failure

DASH diet may protect against heart failure

Product Highlight - Rivaroxaban (Xafariv)

Product Highlight - Rivaroxaban (Xafariv)

Exercise protective against stroke, death in individuals with or without AF

Exercise protective against stroke, death in individuals with or without AF

Mental disorders carry increased long-term mortality risk for patients with permanent pacemakers

Mental disorders carry increased long-term mortality risk for patients with permanent pacemakers