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Eylea (aflibercept) 8 mg with extended 6-month treatment interval recommended for approval in EU – Bayer

Written by | 29 May 2025

Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending a label extension for Eylea 8 mg… read more.

Jazz Pharmaceuticals receives CHMP positive opinion for Ziihera (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer

Written by | 26 May 2025

Jazz Pharmaceuticals plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA  has adopted a positive opinion recommending the conditional marketing authorization of… read more.

FDA approval for the transcatheter aortic valve replacement therapy, the SAPIEN 3 platform, for severe aortic stenosis patients without symptoms – Edwards Life Sciences

Written by | 25 May 2025

Edwards Lifesciences announced that the(FDA has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the… read more.

Rinvoq (upadacitinib) receives U.S. FDA approval for giant cell arteritis – AbbVie

Written by | 24 May 2025

AbbVie announced the FDA has approved Rinvoq (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission… read more.

New data for darolutamide confirm safety and improved efficacy across subgroups of patients with metastatic hormone-sensitive prostate cancer – Bayer

Written by | 23 May 2025

New subgroup data from the Phase III ARANOTE trial show darolutamide plus androgen deprivation therapy (ADT) improved radiological progression-free survival (rPFS) in patients with high and low-volume metastatic… read more.

Argenx announces positive CHMP Opinion for Vyvgart (efgartigimod alfa) subcutaneous injection for chronic inflammatory demyelinating polyneuropathy

Written by | 22 May 2025

Argenx SE announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended European Commission (EC) approval of Vyvgart  1000mg (efgartigimod alfa) for subcutaneous… read more.

New survey provides Insights into diagnosis and treatment journey for people living with alcohol use disorder –  Alkermes

Written by | 21 May 2025

A new online survey conducted by The Harris Poll on behalf of Alkermes, sought to understand utilization of and experiences with treatment among 300 adults between ages 21-64… read more.

Lynozyfic (linvoseltamab) approved in the EU for the treatment of relapsed/refractory multiple myeloma – Regeneron

Written by | 20 May 2025

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM)…. read more.

CHMP adopts a positive opinion, recommending a change to marketing authorisation for Veklury (remdesivir)

Written by | 19 May 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Veklury. The CHMP adopted… read more.

Abbott Integrates Libre’s Data with Epic’s Electronic Health Record System, Providing Healthcare Professionals Seamless Glucose Monitoring Information

Written by | 17 May 2025

Abbott, a global leader in continuous glucose monitoring (CGM) biowearable technology announced that it has entered a first-of-its-kind agreement to integrate data from its leadiing Libre CGM systems… read more.

Vertex Receives CHMP Positive Opinion for Alyftrek, a new once-daily CFTR Modulator for the treatment of cystic fibrosis

Written by | 16 May 2025

Vertex Pharmaceuticals announced that the  EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic… read more.

BioMarin presents new data for Voxzogo (vosoritide) in children with achondroplasia and other skeletal conditions at two international endocrinology meetings

Written by | 15 May 2025

BioMarin Pharmaceutical Inc.  announced new data from studies of Voxzogo (vosoritide), demonstrating meaningful impact on tibial bowing in children with achondroplasia and investigational early efficacy results in other skeletal… read more.

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