Idorsia Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion for the use of Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.
Takeda announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC)
A group of experts from across Canada have developed a national evidence-based treatment guideline to provide healthcare professionals with clear guidance on the management of relapsed or refractory DLBCL. Results of the current provincial guidelines in existence are presented with consensus recommendations based on available evidence.
Utility Therapeutics received approval from the FDA for Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus
Bruker will pay about $392.6 million in cash to acquire most of the assets of Nanostring, a provider of research tools for spatial biology and gene expression according to Nanostring
Takeda announced that the FDA has approved Entyvio (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio
Nora Pharma, a Canadian pharmaceutical company, has received approval for its first biosimilar product. Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the commercialization of Niopeg (a pegylated form of filgrastim) in Canada.
Roche announced that the FDA has approved Alecensa (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours greater than 4 cm or node positive), as detected by an FDA-approved test
Sage Therapeutics, Inc. announced topline results from PRECEDENT, a double-blind, placebo-controlled Phase II study of the investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD)
Eli Lilly and Company announced positive topline results of the SURMOUNT-OSA phase III clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints