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Rezon Bio’s Warsaw-Duchnice facility Receives the US FDA Approval for Commercial Manufacturing 
Shots:  The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility  The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market  This approval follows earlier EMA GMP certification and authorization for commercial…
February 18, 2026
Sandoz
Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) 
Shots:  The US FDA has approved Enzeevu, a biosimilar version of Eylea (aflibercept), for multiple retinal indications, with an anticipated launch in Q4’26   Aflibercept is a recombinant fusion protein that blocks VEGF-A and PlGF, inhibiting abnormal blood vessel growth   Enzeevu (aflibercept-abzv) is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO),…
February 18, 2026
Pfizer New
Pfizer Reports P-III (BREAKWATER) Trial Cohort 3 Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)
Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved PFS as assessed by BICR, with OS showing meaningful prolonged improvement; ORR results were…
February 18, 2026
GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP
Shots: EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72%…
February 17, 2026
Bio-Techne’s Ella Platform Receives the CE-IVD Marking for Rapid, Cartridge‑Based Immunoassays
Shots: Bio-Techne has received the European CE-IVD Mark for Ella benchtop immunoassay platform to produce accurate biomarker results in clinical settings Ella is compatible with Simple Plex assays powered by R&D Systems antibodies & proteins, offering over 390 analytes across neuroscience, immunology, oncology, & cell & gene therapy to ensure consistent, high-quality data across diverse research applications…
February 17, 2026
VB Spine to Acquire Exclusive Rights to xvision Spine System from Augmedics
Shots: VB Spine has entered into a definitive agreement with Augmedics to secure exclusive rights to the xvision Spine System, enhancing precision in open, minimally invasive, & percutaneous spine procedures through advanced augmented reality (AR) navigation tech Acquisition will expand VB Spine’s enhanced visualization portfolio by adding AR navigation capabilities, &, subject to regulatory approvals…
February 17, 2026
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