Johnson & Johnson MedTech, the medical technology arm of Johnson & Johnson (J&J) on Thursday said the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its TRUFILL n-BCA Liquid Embolic System. The device is now cleared for embolization of the middle meningeal artery (MMA)...
Cytokinetics, Incorporated (CYTK) said on Wednesday that China's National Medical Products Administration has approved Myqorzo for the treatment of adults with obstructive hypertrophic cardiomyopathy. Under its license and collaboration agreement, Sanofi holds exclusive rights to develop and commercialize...
Palvella Therapeutics ((PVLA) announced that the FDA has granted Fast Track Designation to QTORIN rapamycin for the treatment of angiokeratomas. The company noted that, if relevant criteria are met, programs with Fast Track designation can become eligible for accelerated approval and priority review. In...
GSK plc (GSK) on Tuesday said the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Exdensur for the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps. The approval was based on data from the Phase III SWIFT and ANCHOR trials, which...
FibroGen, Inc. (FGEN) announced that the Office of Orphan Products Development of the FDA has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes. The company said Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion...
Biopharmaceutical company Arcus Biosciences, Inc. (RCUS) announced Friday the discontinuation of the Phase 3 STAR-221 study, being conducted in partnership with Gilead Sciences, Inc. (GILD), due to futility. The study evaluated a domvanalimab-based combination in upper gastrointestinal cancers. The...
Acadia Pharmaceuticals Inc. (ACAD) on Friday announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE STIX, a powder formulation of DAYBUE oral solution, for the treatment of Rett syndrome in patients aged two years and older. Rett syndrome is a rare neurodevelopmental disorder...
BioCryst Pharmaceuticals, Inc. (BCRX) on Friday said the U.S. Food and Drug Administration has approved an oral pellet formulation of Orladeyo for prophylactic use in pediatric patients aged 2 to under 12 years with hereditary angioedema (HAE). With the new approval, Orladeyo becomes the first and...
Amgen Inc. (AMGN), Friday, announced that the FDA has expanded UPLIZNA's label to include the treatment of generalized myasthenia gravis in adults who are positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies. The approval was based on results from a phase 3 trial,...
Biomerica, Inc. (BMRA), a provider of advanced diagnostic solutions, announced on Thursday that the Egyptian Drug Authority (EDA) has granted authorization for its complete portfolio of rapid tests for conditions related to cancers and chronic diseases. The approval covers Biomerica's at-home tests,...
Bristol Myers Squibb Co. (BMY) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and...
Biopharmaceutical company PTC Therapeutics Canada ULC announced Wednesday that Health Canada has approved Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult...
HeartBeam, Inc. (BEAT), a medical technology company, announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company's groundbreaking 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias. This clearance follows HeartBeam's...
GSK plc (GSK, GSK.L) announced that its B7-H3-targeted antibody-drug conjugate GSK'227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation from the FDA for the treatment of small-cell lung cancer. The ODD was supported by preliminary clinical...
Roche Holding AG (RHHBY) said on Tuesday that the European Commission has approved Gazyva/Gazyvaro, in combination with mycophenolate mofetil (MMF), for the treatment of adult patients with active lupus nephritis. The approval is based on positive results from the phase II NOBILITY and phase III REGENCY...
December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.