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AbbVie showcases breadth and depth of research in Crohn’s disease and ulcerative colitis at UEG Week 2023

Written by | 14 Oct 2023

AbbVie will share new data from its robust gastroenterology portfolio at the United European Gastroenterology (UEG) Week 2023 Congress taking place in Copenhagen, Denmark from October 14-17. AbbVie… read more.

Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer

Written by | 12 Oct 2023

Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology… read more.

MHRA (UK) approves Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults – GSK

Written by | 11 Oct 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults. It can… read more.

Majority of newborn babies with spinal muscular atrophy (SMA) treated with Evrysdi (risdiplam) are able to sit independently after 1 year of treatment – Roche

Written by | 10 Oct 2023

Roche presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi (risdiplam) in babies with pre-symptomatic SMA (n=26), aged… read more.

Takeda provides update on Exkivity (mobocertinib) for epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive NSCLC

Written by | 9 Oct 2023

Takeda announced that, following discussions with the FDA, it will be working with the FDA towards a voluntary withdrawal of Exkivity (mobocertinib) in the U.S. for adult patients… read more.

FDA approves Bosulif (bosutinib) for pediatric Ph+ CP-CML – Pfizer

Written by | 8 Oct 2023

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome (Ph)–positive, chronic-phase chronic myelogenous leukemia (CP-CML) that… read more.

BeiGene announces positive regulatory updates in Europe and the U.S. after recently regaining global rights for Tevimbra (tislelizumab)

Written by | 7 Oct 2023

BeiGene, Ltd. announced that the European Commission (EC) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous… read more.

Health Canada authorization for XBB.1.5-adapted monovalent COVID-19 vaccine – Pfizer + BioNtech SE

Written by | 6 Oct 2023

Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) for ages 6 months and older…. read more.

Padcev and Keytruda significantly improve overall survival and progression-free survival in previously untreated advanced bladder cancer in pivotal phase III EV-302 trial – Seagen + Astellas

Written by | 5 Oct 2023

Seagen Inc. and Astellas Pharma Inc. announced positive topline results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) for Padcev (enfortumab vedotin-ejfv) in combination with… read more.

CE Mark for Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process – Medtronic

Written by | 4 Oct 2023

Medtronic plc announced CE (Conformité Européenne) Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process. The company’s newest no-fingerstick… read more.

Novartis completes divestment of ‘front of eye’ ophthalmology assets

Written by | 3 Oct 2023

Novartis announced that it has completed its divestment of ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up… read more.

European Commission approves Tyruko (natalizumab biosimilar), first and only biosimilar for multiple sclerosis in Europe – Sandoz

Written by | 2 Oct 2023

Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by… read more.

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