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

10 Mar 2025

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

10 Mar 2025

$Seizure freedom may be achieved with surgery in kids with refractory epilepsy, brain tumours$

Seizure freedom may be achieved with surgery in kids with refractory epilepsy, brain tumours

07 Mar 2025

Epilepsy surgery appears beneficial for children with refractory epilepsy and high-grade central nervous system tumours, with a multicentre study showing that the procedure results in seizure freedom in most patients.

Seizure freedom may be achieved with surgery in kids with refractory epilepsy, brain tumours

07 Mar 2025

Role of CGRP in acute migraine treatment and prevention: Evolving strategies and regional insights

07 Mar 2025

This article highlights key insights from the Asia Migraine Healers Academy 2025, a Pfizer-organized event in Kuala Lumpur, Malaysia, where renowned experts Professor Andrew Charles (US) and Dr Mianwang He (China) discussed advancements in migraine management.

Role of CGRP in acute migraine treatment and prevention: Evolving strategies and regional insights

07 Mar 2025

Benralizumab offers durability in EGPA, adds value to patients switched from mepolizumab

07 Mar 2025 by

The attainment of remission in EGPA is durable whether treated with benralizumab for 2 years or switched to benralizumab after 52 weeks of mepolizumab treatment, with additional merits observed among those who switched, as indicated in the OLE of MANDARA

Benralizumab offers durability in EGPA, adds value to patients switched from mepolizumab

07 Mar 2025

Adjunctive intra-arterial lytics bounce back in ANGEL-TNK, PEARL trials

07 Mar 2025 by

Two trials presented at ISC 2025 support intra-arterial thrombolysis as an adjunct to stroke thrombectomy in patients with large-vessel occlusions (LVOs).

Adjunctive intra-arterial lytics bounce back in ANGEL-TNK, PEARL trials

07 Mar 2025

Foetal malformation risk high in ART-conceived pregnancies of women with epilepsy

06 Mar 2025

Conception via assisted reproductive technology (ART) carries an increased risk of foetal malformation among women with epilepsy, according to a study.

Foetal malformation risk high in ART-conceived pregnancies of women with epilepsy

06 Mar 2025

No cardiovascular signal with anti-CGRP mAbs for migraine

05 Mar 2025

Migraine treatment with monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) or its receptor does not appear to contribute to increased risk of cardiovascular disease (CVD) compared with onabotulinumtoxinA in adults, including those who are older and with disability, according to a retrospective cohort study.

No cardiovascular signal with anti-CGRP mAbs for migraine

05 Mar 2025

Postresuscitation care of OHCA patients lacks neuroprotection

03 Mar 2025 by

A considerable variability exists in postresuscitation care of patients with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA) at the emergency department (ED), which suggests gaps between recommended guidelines and clinical practice, according to a Singapore study.

Postresuscitation care of OHCA patients lacks neuroprotection

03 Mar 2025

Novel BXOS110 promising neuroprotective agent in acute ischaemic stroke

28 Feb 2025 by

BXOS110, a novel PSD-95* protein inhibitor, has shown potential for improving functional outcomes in patients with acute ischaemic stroke, according to the BEST** trial presented at ISC 2025.

Novel BXOS110 promising neuroprotective agent in acute ischaemic stroke

28 Feb 2025

Progressively higher-intensity walking plus PT enhances stroke recovery

26 Feb 2025 by

Augmenting standard physical therapy (PT) with a progressively higher-intensity walking exercise programme in inpatient stroke rehabilitation units improved mobility and quality of life (QoL) in stroke survivors, a study has shown.

Progressively higher-intensity walking plus PT enhances stroke recovery

26 Feb 2025

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

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

Seizure freedom may be achieved with surgery in kids with refractory epilepsy, brain tumours

Seizure freedom may be achieved with surgery in kids with refractory epilepsy, brain tumours

Role of CGRP in acute migraine treatment and prevention: Evolving strategies and regional insights

Role of CGRP in acute migraine treatment and prevention: Evolving strategies and regional insights

Benralizumab offers durability in EGPA, adds value to patients switched from mepolizumab

Benralizumab offers durability in EGPA, adds value to patients switched from mepolizumab

Adjunctive intra-arterial lytics bounce back in ANGEL-TNK, PEARL trials

Adjunctive intra-arterial lytics bounce back in ANGEL-TNK, PEARL trials

Foetal malformation risk high in ART-conceived pregnancies of women with epilepsy

Foetal malformation risk high in ART-conceived pregnancies of women with epilepsy

No cardiovascular signal with anti-CGRP mAbs for migraine

No cardiovascular signal with anti-CGRP mAbs for migraine

Postresuscitation care of OHCA patients lacks neuroprotection

Postresuscitation care of OHCA patients lacks neuroprotection

Novel BXOS110 promising neuroprotective agent in acute ischaemic stroke

Novel BXOS110 promising neuroprotective agent in acute ischaemic stroke

Progressively higher-intensity walking plus PT enhances stroke recovery

Progressively higher-intensity walking plus PT enhances stroke recovery