All Blogs
Nov 12, 2026
FX Shoulder Solutions Secures EU MDR Certification for Humelock Reversed® Shoulder System; Bechtel Medical’s Wound VOX™ Receives FDA 510(k) Clearance; MRP Launches VYDENCE ZYE Ultra Multi-Platform Aesthetic Laser System; Health Canada Authorizes Moderna’s mRNA Flu and Flu-COVID-19 Vaccines; i-Lumen Presents i-SIGHT Feasibility Study Findings at CTS Retina 2026; CaliberMRI Launches Quantitative MRI Phantom for Preclinical High-Field Systems
FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed® Shoulder System On 03 November 2026, FX Shoulder Solutions, Inc. received European Union Medical Device Regulation (EU MDR 2017/745) certification for its Humelock Reversed Shoulder System, marking an important regulatory mile...
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Nov 13, 2026
6 HER2 NSCLC Pipeline Therapies Poised to Unlock New Market Opportunities
Summary HER2 mutations are detected in approximately 1–5% of NSCLC patients, although the actual prevalence may be underestimated due to limited next-generation sequencing (NGS) adoption, particularly in community settings, where testing rates remain below 50%. The approval of AstraZeneca and Daiichi Sankyo’...
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Nov 11, 2026
The Patent Cliff Countdown: 8 Pharma Giants With the Most Revenue on the Line
Summary More than $300 billion of annual revenue, about one-sixth of the industry, loses exclusivity between 2025 and 2030, roughly three times the 2012 cliff. Branded sales can fall 80–90% within 12 to 18 months of generic or biosimilar entry, and US Medicare price negotiation can cut net prices even earlie...
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Nov 10, 2026
argenx’s ALKIVIA Phase 3 Study Demonstrates Rapid and Durable Clinical Improvement with Efgartigimod in Autoimmune Myositis; Johnson & Johnson Reports Phase 2 Nipocalimab Data in Sjögren’s Disease Highlighting Patient-Prioritized Symptom Improvements; Immunocore Unveils Promising Brenetafusp–KIMMTRAK Data in Metastatic Uveal Melanoma; Real-World Study Shows REPATHA Cuts Heart Attack Risk by 20% Compared with Ezetimibe; Health Canada Approves Moderna’s mRNA Flu Vaccine and Combined Influenza-COVID-19 Vaccine
argenx Shares Phase 3 ALKIVIA Evidence of Rapid and Sustained Efgartigimod Response in Autoimmune Myositis argenx SE announced that findings from the Phase 3 ALKIVIA study, highlighting the rapid and sustained clinical improvement achieved with VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patie...
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Nov 09, 2026
Top 5 Late-Stage Intratumoral Cancer Therapies Redefining the Oncology Pipeline
Summary Intratumoral cancer therapies represent an emerging immunotherapy approach that directly targets the tumor microenvironment, enhances localized drug delivery, minimizes systemic toxicity, and potentially converts immunologically cold tumors into hot tumors responsive to immune-based treatment. Despit...
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Nov 06, 2026
GSK/Ionis’ HIBSAGO: How the First FDA-Approved Antisense Drug for Chronic Hepatitis B Could Change the Treatment Arena
Summary On October 20, 2026, the FDA approved HIBSAGO (bepirovirsen), the first antisense oligonucleotide for chronic hepatitis B, from Ionis and GSK. In the B-Well trials, 19% reached functional cure at week 72 versus 0% on placebo, and 26% when baseline HBsAg was 1,000 IU/mL or less. About 16 developers...
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Nov 05, 2026
FX Shoulder Solutions Secures EU MDR Approval for Humelock Reversed; Beckman Coulter Diagnostics Wins FDA Clearance for 15-Minute Bacterial-Viral Assay; Laza Medical Secures Series B Funding of Up to $160 Million to Transform Interventional Imaging; Medtronic Partners with Michael J. Fox Foundation to Expand Parkinson’s DBS Awareness and Reports Significant Blood Pressure Reductions with Symplicity in SPYRAL AFFIRM Real-World Study; SetPoint Medical Marks New Mexico Milestone with First SetPoint® System Procedures
FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed® Shoulder System On 03 November 2026, FX Shoulder Solutions, Inc. received European Union Medical Device Regulation (EU MDR 2017/745) certification for its Humelock Reversed Shoulder System, marking an important regulatory mile...
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Nov 04, 2026
The Blood-Brain Barrier: Transforming the Future of CNS Drug Development
The human brain is guarded by one of biology's most selective security systems, and it turns away nearly every large-molecule drug that tries to get in. Cracking the blood-brain barrier (BBB) has become one of the most competitive races in modern biotech, with the first approved transferrin-receptor "shuttle" biolo...
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Nov 03, 2026
INOVIO’s VOCERYQ Receives FDA Accelerated Approval for Adult RRP; AbbVie Submits Etentamig Biologics License Application to FDA for R/R Multiple Myeloma; Setara Biosciences Raises $90 Million Series A to Advance Rare Disease Precision Medicines; BioMarin Expands Fabry Disease Portfolio With Exclusive Global License for Next-Generation ERT; Pfizer’s ELREXFIO Advances Multiple Myeloma Treatment With Positive Phase 3 Results
INOVIO Announces Accelerated FDA Approval for VOCERYQ in Adult RRP INOVIO announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), formerly known as INO-3107, for reducing the frequency of surgical inter...
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Nov 02, 2026
AstraZeneca’s ULTOMIRIS: The First C5 Inhibitor Enters the Race to Tame Proteinuria in IgA Nephropathy
Summary FDA granted accelerated approval to AstraZeneca’s ULTOMIRIS on October 21, 2026, to reduce proteinuria in adults with primary IgAN at risk of progression. It is the fifth US rare disease indication for ULTOMIRIS and the first and only C5 inhibitor approved for this use. In I CAN, 24-hour UPCR fell...
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