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Merck new
NEWS

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Shots: The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…
November 20, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…
November 19, 2025

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NEWS

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…
November 19, 2025

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Merck new
NEWS

Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF

Shots: Merck has reported topline P-II (CADENCE) trial data assessing Winrevair (sotatercept-csrk; 0.3 or 0.7mg/kg) vs PBO in 164 pts with CpcPH due to heart failure with preserved ejection fraction (HFpEF) Trial met its 1EP, showing a reduction in pulmonary vascular resistance at 24wks. along with a favorable safety profile. Data will be presented at a…
November 19, 2025

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GSK and LTZ Therapeutics
NEWS

GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology

Shots: GSK has entered into a strategic research collaboration with LTZ Therapeutics to advance the development of novel myeloid cell engagers (MCEs) in oncology, leveraging LTZ’s immune-engager platform Under the collaboration, GSK & LTZ aim to develop up to four MCE therapies for hematologic cancers & solid tumors, with GSK receiving an exclusive option to…
November 19, 2025

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Arrowhead Pharmaceuticals
NEWS

Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The US FDA has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; US availability is expected by year-end Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…
November 19, 2025

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Genmab and AbbVie
NEWS

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

Shots: The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in…
November 19, 2025

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Genentech
NEWS

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…
November 18, 2025

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