Subscribe
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Archive

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.

Bayer submits application in China for third indication of darolutamide

Written by | 13 Jan 2025

Bayer has filed an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for marketing authorization of the oral androgen receptor inhibitor… read more.

MHLW (Japan) approves Zepbound (tirzepatide) to treat obesity – Eli Lilly KK + Mitsubishi Tanabe

Written by | 12 Jan 2025

Eli Lilly Japan K.K. and Mitsubishi Tanabe Pharma Corporation  announced that Eli Lilly Japan received manufacturing and marketing authorization in Japan from the Japanese Ministry of Health, Labour… read more.

New data from three oral presentations, showing significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma patients presented at ASH meeting – Sanofi

Written by | 11 Jan 2025

New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma (NDMM) patients were featured at the 66th American Society… read more.

Marinus regains commercial rights in Europe for ganaxolone from Orion Pharma

Written by | 8 Jan 2025

30 December 2024-Orion Corporation  and Marinus Pharmaceuticals, Inc. have decided to mutually terminate their European wide marketing and distribution agreement for ganaxolone. Marinus regains ganaxolone’s commercial rights in… read more.

European Commission approves Yselty (linzagolix) for the symptomatic treatment of endometriosis – Theramex

Written by | 7 Jan 2025

Theramex, a global pharmaceutical company dedicated to women’s health, is pleased to announce that the European Commission (EC) has approved an extended indication for Yselty (linzagolix), an oral… read more.

NICE (UK) positive for Zepbound (tirzepatide) for managing overweight and obesity – Eli Lilly

Written by | 6 Jan 2025

NICE (UK): 1.1 Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity in adults, only if they have:… read more.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Subscribe

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.