NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…

January 28, 2026

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Shots: The US FDA approved Myqorzo (aficamten) is now commercially available in the US for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms Myqorzo is a QD, oral cardiac myosin inhibitor available in 5, 10, 15, and 20 mg tablets and directly targets hypercontractility and LVOT obstruction…

January 28, 2026

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Shots: Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…

January 28, 2026

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

Shots: Boehringer Ingelheim and Simcere have entered a license and collaboration agreement to develop SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody, for the treatment of inflammatory bowel disease (IBD) As per the deal, Boehringer Ingelheim gains global rights to the asset excluding Greater China, while Simcere is eligible for an upfront payment, milestones up to €1.058B…

January 28, 2026

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…

January 28, 2026

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…

January 28, 2026

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The EC has approved the Arexvy RSV vaccine for adults ≥18 yrs in Europe. While it was previously authorized only for adults ≥50 yrs at risk The adjuvanted RSV vaccine includes a stabilized form of a protein from the respiratory syncytial virus (RSV), called the prefusion F protein (RSVPreF3), combined with GSK’s AS01E adjuvant,…

January 27, 2026

Neurocrine Biosciences Initiates P-II Study of NBI-1065890 to Treat Tardive Dyskinesia (TD) in Adults

Shots: Neurocrine Biosciences has initiated a P-II study of investigational NBI-1065890 in adults with TD P-II study of NBI-1065890 will enroll ~100 adults with TD, evaluating efficacy, safety, and tolerability, with the 1EP being change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Wk 8 NBI-1065890 is a selective oral VMAT2 inhibitor…

January 27, 2026

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…

January 27, 2026

BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…

January 27, 2026

NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

Neurocrine Biosciences Initiates P-II Study of NBI-1065890 to Treat Tardive Dyskinesia (TD) in Adults

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

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