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European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer – GSK

Written by | 26 Jan 2025

GSK plc announced the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent… read more.

FDA approves Omvoh (mirikizumab-mrkz) for Crohn’s disease, expanding its use to the second major type of IBD – Eli Lilly

Written by | 25 Jan 2025

Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh is now approved… read more.

Elucidation of part of the mechanism by which lecanemab slows the progression of Alzheimer’s disease – Eisai

Written by | 24 Jan 2025

A collaborative research group led by Professor Kenjiro Ono of the Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, and Eisai Co., Ltd., used a newly developed… read more.

MHRA (UK) approves Jeragyo (aprocitentan) to treat resistant hypertension – Idorsia

Written by | 23 Jan 2025

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jeraygo (aprocitentan) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled… read more.

Novo Nordisk announced headline results from STEP UP, a phase IIIb trial investigating subcutaneous semaglutide 7.2 mg for obesity

Written by | 22 Jan 2025

Novo Nordisk  announced headline results from STEP UP, a phase IIIb trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous… read more.

Late-breaking data presented at AF Symposium 2025 highlight key Boston Scientific therapies for management of patients with atrial fibrillation

Written by | 21 Jan 2025

Boston Scientific Corporation (announced data supporting the use of the FARAPULSE Pulsed Field Ablation (PFA) System  during a late-breaking science session at AF Symposium 2025. Currently, the FARAPULSE… read more.

Bayer submits application to the FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need

Written by | 20 Jan 2025

Bayer announced the submission of marketing authorization applications to the FDA and to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval… read more.

Euroopean Commission approves Vabysm (faricimab) pre-filled syringe for neovascular or ‘wet’ age-related macular degeneration, diabetic macular edema and macular edema following RVO – Roche

Written by | 18 Jan 2025

Roche announced that the European Medicines Agency has approved Vabysmo  (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular… read more.

Shingrix new prefilled syringe presentation accepted for review by US FDA – GSK

Written by | 17 Jan 2025

GSK plc  announced that the FDA has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention… read more.

NICE (UK) positive for Kimmtrak (tebentafusp) for treating advanced uveal melanoma – Immunocore Ltd

Written by | 16 Jan 2025

NICE (UK): 1.1 Tebentafusp is recommended, within its marketing authorisation, for treating HLA‑A*02:01-positive unresectable or metastatic uveal melanoma in adults. Tebentafusp is only recommended if the company provides… read more.

Exceptional launch for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease – Verona Pharma

Written by | 15 Jan 2025

Verona Pharma plc  announces preliminary unaudited net product sales for the fourth quarter and full year ended December 31, 2024, and provides a corporate update. “2024 was another… read more.

European Commission approves extended indication for Palforzia (defatted powder of Arachis hypogaea L semen (peanut)) for toddlers with a confirmed diagnosis of peanut allergy – Stallergenes Greer

Written by | 14 Jan 2025

Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), announces that the European Commission (EC) has approved the extension of indication of Palforzia  (defatted powder of Arachis hypogaea L.,… read more.

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