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European approval for Itulazax (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents – ALK

Written by | 5 Jun 2025

ALK-Abello announced that its European regulatory filing for Itulazax (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents aged five to 17 has been… read more.

BATURA Phase III trial results provide new evidence for Airsupra as standard of care for as-needed rescue treatment in asthma – AstraZeneca

Written by | 4 Jun 2025

Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, Airsupra (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and… read more.

FDA approves MenQuadfi meningococcal vaccine for children 6 weeks or older – Sanofi

Written by | 3 Jun 2025

The FDA has approved an expanded indication of Sanofi’s quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W,… read more.

UK MHRA grants marketing authorization in the UK for Vimkunya vaccine for the prevention of disease caused by chikungunya virus in individuals 12 years and older – Bavarian Nordic

Written by | 2 Jun 2025

Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for Vimkunya (recombinant, adsorbed) for… read more.

Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients – Medtronic

Written by | 1 Jun 2025

Medtronic plc announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera family of technologies, including the next-generation Sphere-360 single-shot pulsed field… read more.

Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone – AstraZeneca

Written by | 31 May 2025

Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free… read more.

MHRA (UK) approves Hympavzi (marstacimab) to treat haemophilia A or B in adult and paediatric patients – Pfizer

Written by | 30 May 2025

Hympavzi (marstacimab) from Pfizer has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A or B in adult and paediatric patients…. read more.

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.

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