KEYTRUDA® Combined with Padcev® Significantly Boosts Event-Free Survival, Overall Survival, and Pathologic Complete Response Rates in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Administered Perioperatively Merck, known as MSD outside the United States and Canada, today announced positive topline results…
U.S. FDA Approves RYBREVANT® FASPRO™ (amivantamab and hyaluronidase-lpuj), Offering the Shortest and Simplest Administration Time for a First-Line Combination Regimen with LAZCLUZE® (lazertinib) Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and…
Argenx Shares Update on UplighTED Clinical Trials of Subcutaneous Efgartigimod for Thyroid Eye Disease Argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Phase 3 UplighTED studies…
Exdensur (depemokimab) Approved in the UK for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps GSK plc today announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now…
Enhertu plus pertuzumab approved in the U.S. as the first new first-line treatment in a decade for HER2-positive metastatic breast cancer AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment…
Cytokinetics Announces Positive CHMP Opinion for MYQORZO® in Obstructive HCM Cytokinetics, Incorporated today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the…
Aflibercept 8 mg Recommended for EU Approval for Third Retinal Indication The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in…
Merck Receives Positive CHMP Opinion in the EU for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH; WHO Group 1 Pulmonary Hypertension) Merck, known as MSD outside of the United States and Canada, today announced that…
U.S. FDA Approves AKEEGA®—First Precision Therapy for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer, Cutting Disease Progression by 54% Compared to Standard of Care* Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approvedthe supplemental New Drug Application (sNDA)…
Novo Nordisk A/S: EMA Recommends Higher-Dose Wegovy® for Obesity, Delivering Average Weight Loss of 20.7% Today, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy® (semaglutide 7.2…
Alnylam Announces Partial Buyback of 1.00% Convertible Senior Notes Maturing in 2027 Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced today that it has entered into separate, privately negotiated repurchase agreements with certain holders of its 1.00% Convertible Senior Notes…
Roche Expands Automated Mass Spectrometry Portfolio with CE Mark Approval for Antibiotic Drug Monitoring, Delivering the Industry’s Broadest IVD Menu Roche announced today that it has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring.…