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FDA provides supplemental approval for Spravato (esketamine) CIII nasal spray, for adults living with major depressive disorder – Johnson & Johnson

Written by | 2 Feb 2025

Johnson & Johnson  announced the FDA approval of a supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray, making this innovative treatment the first and only… read more.

Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency – GSK

Written by | 1 Feb 2025

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

Datroway approved in the U.S. for patients with previously treated metastatic HR Positive, HER2 negative breast cancer – Daiichi Sankyo

Written by | 31 Jan 2025

Datroway  (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC… read more.

Complete analysis of NORSE EIGHT trial evaluating ONS 5010 in wet AMD patients – Outlook Therapeutics

Written by | 30 Jan 2025

Outlook Therapeutics, Inc.,  announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled… read more.

CHMP positive for Nemluvio (nemolizumab) for the treatment of both atopic dermatitis and prurigo nodularis – Galderma

Written by | 27 Jan 2025

Galderma  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing… read more.

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.

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