Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) to expand the indication of Zoryve (roflumilast) cream 0.3% for the topical treatment of… read more.
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.
Neurelis, Inc., announced additional findings from the post hoc analysis of the long-term phase III safety study of Valtoco (diazepam nasal spray) in a pediatric population, aged 6-17… read more.
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.
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.
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 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.
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, 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.
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.
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.
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.
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