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Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years – Bayer

Written by | 28 Oct 2024

Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years,… read more.

CHMP positive for Kevzara (sarilumab) to treat polymyalgia rheumatica – Sanofi

Written by | 27 Oct 2024

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

MHRA (UK) approves donanemab to treat mild cognitive impairment and mild dementia in the UK – Eli Lilly

Written by | 26 Oct 2024

Eli Lilly and Company announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks… read more.

Gilead Sciences to withdraw Trodelvy (sacituzumab govitecan-hziy) for bladder cancer in the US

Written by | 25 Oct 2024

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy (sacituzumab goviteca-hziy) as a bladder cancer treatment in the U.S. Gilead Sciences announced… read more.

CHMP positive for Flucelvax vaccine to prevent influenza

Written by | 24 Oct 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Flucelvax, intended for the prevention of influenza… read more.

FDA approves the Versius Surgical System

Written by | 23 Oct 2024

CMR Surgical announced that the FDA has granted marketing authorization for the Versius Surgical System (Versius), paving the way for a next-generation versatile, adaptable, and digitally driven surgical… read more.

FDA approves Vyalev (foscarbidopa + foslevodopa) subcutaneous 24-hour infusion of levodopa-based therapy for advanced Parkinson’s disease – AbbVie

Written by | 22 Oct 2024

AbbVie announced that the FDA has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations… read more.

Majority of children with spinal muscular atrophy treated with Evrysdi (risdiplam) are able to sit, stand and walk independently, two-year data demonstrate – Genentech/Roche

Written by | 21 Oct 2024

Genentech, a member of the Roche Group  presented positive 2-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society (WMS) Congress, October 8-12, 2024, assessing… read more.

Updated 2024-2025 Nuvaxovid COVID-19 Vaccine (NVX-CoV2705) receives authorization in the EU – Novavax

Written by | 20 Oct 2024

9 October 2024-Novavax, Inc. announced that the European Commission granted Marketing Authorization for Novavax’s updated 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in… read more.

Application submitted for third indication of darolutamide in the EU – Bayer

Written by | 19 Oct 2024

Bayer announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use… read more.

FDA approves Hympavzi for the treatment of adults and adolescents with hemophilia A or B without inhibitors – Pfizer

Written by | 18 Oct 2024

Pfizer Inc. announced  that the FDA has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12… read more.

FDA approval for 320 mg single-injection device presentations of Bimzelx – UCB

Written by | 17 Oct 2024

UCB  announced that the FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx). These new device presentations add to… read more.

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