GE HealthCare announced the launch of Invenia Abus (Automated Breast Ultrasound) Prime and Abus StreamVue, a redesigned enterprise viewer that recently received FDA 510(k) clearance and CE Marking,… read more.
Arcutis Biotherapeutics announced that the FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of… read more.
Genmab A/S announced that the European Commission (EC) granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R2) for the treatment of adult… read more.
Novartis announced the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic… read more.
AbbVie announced that the EC has approved Rinvoq (upadacitinib; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients 12 years and older… read more.
Arcutis Biotherapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05% to expand the indication for the topical treatment of… read more.
Novartis announced that the European Commission (EC) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with spinal muscular… read more.
Sanofi announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants… read more.
Medtronic announced an expanded CE Mark indication for the Affera Mapping and Ablation System with Sphere-9 Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular… read more.
Merck announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for Enflonsia (clesrovimab-cfor) to expand its indication to include prevention of respiratory syncytial virus (RSV)… read more.
Daiichi Sankyo and AstraZeneca announced that Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable… read more.
Replimune Group announced that the FDA has granted accelerated approval for TudriqevTM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults… read more.
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