All Blogs
Aug 21, 2026
T-Cell Malignancies: The Evolving Treatment Landscape and the Race for Market Leadership
Summary T-cell malignancies, including Peripheral T-cell Lymphomas (PTCL) and cutaneous entities such as Cutaneous T-cell Lymphoma (CTCL), comprise a diverse and often aggressive group of cancers that are generally associated with poorer clinical outcomes compared with B-cell malignancies. The current CTCL t...
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Aug 20, 2026
Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial
Empatica Received FDA Clearance for Parkinson's Monitoring On 19 August 2026, Empatica announced that its Health Monitoring Platform for Parkinson’s disease had received 510(k) clearance from the U.S. Food and Drug Administration. The clearance expanded Empatica’s clinical-grade monitoring capabilities int...
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Aug 19, 2026
The Digital Biomarkers Revolution: How Wearables Are Redefining Healthcare?
A decade ago, a heart-rate spike at 2 a.m. would have gone unnoticed until a patient's next check-up, if it was noticed at all. Today, that same spike can trigger an alert on a smartwatch, get flagged by an algorithm trained on millions of similar events, and land in a cardiologist's dashboard before the patient ev...
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Aug 18, 2026
AstraZeneca Discontinues Phase III eVOLVE-Lung02 Trial of Volrustomig in Metastatic NSCLC; argenx Announces Favorable Topline Results from Phase 3 ALKIVIA Study of Efgartigimod; Bristol Myers Squibb’s ZENBEXUS Receives U.S. FDA Accelerated Approval in Combination with Daratumumab and Dexamethasone for Multiple Myeloma; Zealand Pharma Secures USD 100 Million in Royalty Financing Through Agreement with Royalty Pharma for Rusfertide; PTC Advances Rare Disease Strategy with Acquisition of ST-920 Fabry Disease Program
AstraZeneca Ends eVOLVE-Lung02 Phase III Trial Evaluating Volrustomig Plus Chemotherapy AstraZeneca has decided to discontinue the Phase III eVOLVE-Lung02 trial, which was assessing volrustomig in combination with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer (mNS...
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Aug 17, 2026
TYK2 Inhibitors: The Competitive Race Fueling the Next Generation of Autoimmune Therapies
Summary TYK2 inhibitors are emerging as a major class of oral immunology therapies, aiming to combine biologic-level efficacy with the convenience of a pill and fewer safety concerns than broader JAK inhibitors. Bristol Myers Squibb’s SOTYKTU remains the first approved TYK2 inhibitor and expanded its positio...
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Aug 14, 2026
Replimune Strengthens Oncology Portfolio With TUDRIQEV Approval
Summary On August 6, 2026, the FDA granted accelerated approval to Replimune’s TUDRIQEV (vusolimogene oderparepvec-wtpg), formerly known as RP1, in combination with Bristol Myers Squibb’s OPDIVO (nivolumab). The therapy is indicated for adults with unresectable, advanced cutaneous melanoma whose disease has ...
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Aug 13, 2026
Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial
Leica Biosystems Expanded Digital Pathology Portfolio with Multiple FDA Clearances On 11 August 2026, Leica Biosystems announced that it had received multiple U.S. FDA 510(k) clearances for its connected clinical digital pathology portfolio. The regulatory clearances strengthened the company's digital path...
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Aug 12, 2026
Artificial Pancreas Device Systems: Engineering a New Era in Diabetes Management
For a century, insulin therapy has kept people with Type 1 diabetes alive, but it has never fully replicated the second-by-second responsiveness of a healthy pancreas. Artificial Pancreas Device Systems (APDS) close that gap. By pairing continuous glucose monitoring with algorithm-driven insulin pumps, these system...
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Aug 11, 2026
Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals
Sobi Licenses Lacutamab from Innate Pharma to Advance Treatment of T-Cell Lymphoma Swedish Orphan Biovitrum AB (Sobi®) and Innate Pharma SA have announced a strategic partnership aimed at enabling the initiation of the TELLOMAK-3 confirmatory Phase 3 trial of lacutamab in cutaneous T-cell lymphoma (CTCL). The st...
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Aug 10, 2026
BENLYSTA vs GAZYVA: Who Wins the Battle for Lupus Nephritis Treatment?
Summary Lupus nephritis treatment is entering a new phase, shifting from broad immunosuppressants to targeted biologics, with BENLYSTA (belimumab) and GAZYVA (obinutuzumab) emerging as key competitors. BENLYSTA is the established benchmark, with over a decade of clinical use in SLE and approvals for lupus ne...
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