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Merck
NEWS

Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…
October 30, 2025

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Merck new
NEWS

Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear Cell Renal Cell Carcinoma (RCC)

Shots: Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy Trial showed significantly improved disease-free survival (1EP), with OS as 2EP under evaluation; data to be presented in future & shared…
October 29, 2025

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Roche
NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Shots: Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…
October 28, 2025

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Astrazeneca
NEWS

AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1) Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…
October 28, 2025

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Merck new
NEWS

Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)

Shots: The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or III Approval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR…
October 27, 2025

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
October 27, 2025

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