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Eylea 8 mg pre-filled syringe approved in the EU – Bayer

Written by | 14 Sep 2024

The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. The new… read more.

Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by FDA – Gilead Sciences

Written by | 13 Sep 2024

Gilead Sciences, Inc. announced that the FDA has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA)… read more.

Publication of RESTORE data highlighting challenges with twice-nightly oxybates and strong patient preference for once-nightly Lumryz dosing (sodium oxybate) extended-release oral suspension – Avadel Pharma

Written by | 12 Sep 2024

Avadel Pharmaceuticals plc , announced the publication of final data from the RESTORE open-label/switch study, demonstrating that people with narcolepsy prefer once-at-bedtime Lumryz versus a twice-nightly immediate-release oxybate treatment… read more.

Presentation at European Society of Cardiology demonstrates VIVO accuracy in complex ventricular tachycardia patients – Catheter Precision Inc

Written by | 11 Sep 2024

Catheter Precision, Inc. announced that at the recently held European Society of Cardiology (ESC) Symposium, interim results demonstrating the use of VIVO in localizing the site of origin… read more.

FDA approves pediatric indication extension for Palforzia (arachis hypogaea) oral immunotherapy for treatment of peanut allergy – Stallergenes Greer

Written by | 10 Sep 2024

Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, announced that the FDA has approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers… read more.

The European Ccommission approves Avzivi, a biosimilar referencing bevacizumab – Bio Thera Solutions

Written by | 9 Sep 2024

The European Medicines Agency (EMA) has approved Avzivi (BAT 1706), a biosimilar referencing bevacizumab (Avastin), according to an announcement from Bio-Thera Solutions. Avzivi is intended for the treatment… read more.

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need – Bayer

Written by | 8 Sep 2024

Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia/ Firialta) showed a statistically significant improvement in cardiovascular outcomes in patients with heart… read more.

European Commission approves EUR Neffy (epinephrine nasal spray) for emergency treatment of severe allergic reactions in adults and children – ARS Pharma

Written by | 7 Sep 2024

ARS Pharmaceuticals, Inc. announced the European Commission’s approval of EURneffy for emergency treatment of severe allergic reactions in adults and children weighing at least 30 kilograms. This approval… read more.

Nucala (mepolizumab) approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps – GSK

Written by | 6 Sep 2024

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic… read more.

FDA clears Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by people with type 2 diabetes – Insulet Corporation

Written by | 5 Sep 2024

Insulet Corporation , the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5)… read more.

European Commission approves Balversa (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma – Janssen Cilag (J&J)

Written by | 4 Sep 2024

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for the treatment of adult… read more.

Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma – Regeneron Pharma

Written by | 3 Sep 2024

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse… read more.

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