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NEWS

Samsung Bioepis
Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)
Shots: Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…
May 29, 2026
Astrazeneca
AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…
May 29, 2026
Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation
Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…
May 28, 2026
Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software
Shots: The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms The Software integrates its CardioTag wearable sensor with AI to…
May 28, 2026
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