The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) from AstraZeneca and Daiichi Sankyo has been accepted and awarded Priority Review status in the US for treating adult patients with locally advanced or metastatic...
Roche announced that it has obtained 510(k) approval from the United States Food and Drug Administration (FDA) for its ultra-sensitive in-situ hybridisation (ISH) assay, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. The assessment...
Cycle Pharmaceuticals, Inc. (Cycle) has announced the successful acquisition of Banner Life Sciences, LLC (Banner), which encompasses its BAFIERTAM® (monomethyl fumarate) product for treating relapsing forms of multiple sclerosis (MS) in adults...
Pharma lobby group Federation of Pharma Entrepreneurs (FOPE) has urged the government to extend the deadline for compliance with the revised Schedule M by two years. This comes as the government is nearing finalisation of a draft notification...
Mineralys Therapeutics, Inc., a biopharmaceutical company in clinical development concentrating on creating therapies for hypertension, chronic kidney disease (CKD), and other ailments linked to dysregulated aldosterone, revealed that the US Food...
The World Health Organization (WHO) has prequalified the initial diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which can assist in the safe administration of WHO-approved treatments to prevent recurrence of Plasmodium...
Roche announced that its complete slide imaging system, Roche Digital Pathology Dx, has obtained an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA). This approval alters the one Roche obtained on June 14, 2024, for Ro...
Dizal, a biopharmaceutical firm dedicated to creating innovative therapies for cancer and immunological disorders, revealed that the U.S. Food and Drug Administration (FDA) has accepted and assigned priority review to the company's New Drug...
JCR Pharmaceuticals Co., Ltd., a worldwide specialty pharmaceuticals firm, and Modalis Therapeutics Corporation, a leader in epigenetic medicine, have revealed that they have confirmed the preliminary proof of concept in a joint research programme...
Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical firm dedicated to creating a novel class of small molecule antibiotics for challenging bacterial infections, announced that it has obtained positive regulatory guidance from the EMA in...
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