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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.

Medtronic announces strongly positive results for patients from procedural and design innovation of Evolut TAVR

Written by | 5 Jan 2025

Medtronic plc announced new data for the Evolut Transcatheter Aortic Valve Replacement System (TAVR) at PCR London Valves 2024. This new clinical evidence brings further insights to global… read more.

Supplemental approval of Opdivo + cisplatin + gemcitabine for treatment of unresectable urothelial carcinoma in Japan – Ono Pharma

Written by | 4 Jan 2025

Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K.  announced that Ono has received a supplemental approval of Opdivo (generic name: nivolumab) Intravenous Infusion (“Opdivo”), an anti-PD-1 antibody, in… read more.

FDA approves Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma – Checkpoint Therapeutics

Written by | 3 Jan 2025

Checkpoint Therapeutics, Inc. announced that the FDA has approved Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who… read more.

New and updated data for Roche’s fixed-duration Lunsumio at ASH 2024 reinforce its potential to improve outcomes for people with lymphoma – Roche

Written by | 2 Jan 2025

Roche announced  that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting &… read more.

Results from phase III NATALEE trial of Kisqal (ribociclib) + endocrine therapy show sustained reduction of recurrence in HER+/HER2- early breast cancer – Novartis

Written by | 31 Dec 2024

Novartis announced results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqal (ribociclib) that underscore the extended efficacy beyond the duration of treatment in… read more.

FDA grants approval of Crenessity (crinecerfont), a first-in-class treatment for children and adults with classic congenital adrenal hyperplasia – Neurocrine Biosciences

Written by | 30 Dec 2024

Neurocrine Biosciences, Inc. announced the FDA approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years… read more.

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