Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

ByRidhi RastogiFebruary 27, 2026

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Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Shots: Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases Trial showed improved OS (2EP), with a 24% reduction in death risk &…

ByRidhi RastogiFebruary 27, 2026

NEWS

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Shots: The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…

ByRidhi RastogiFebruary 26, 2026

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Novartis Reports the CHMP Positive Opinion for Remibrutinib for Chronic Spontaneous Urticaria (CSU)

Shots: The CHMP has recommended approval of remibrutinib for CSU in adults with inadequate response to H1-antihistamines, with a final decision from the EC expected within ~2 mos. Opinion was supported by the global P-III REMIX-1 & 2 trials in 925 pts uncontrolled on second-generation H1-antihistamines, where remibrutinib showed superiority vs PBO in ISS7, HSS7 & UAS7 at Wk 12, with itch and hive improvement from Wk 1 sustained to Wk 52, along with…

ByDipanshu DixitFebruary 26, 2026

NEWS

Moderna’s mCOMBRIAX Receives the CHMP Positive Opinion to Protect Against Influenza and COVID-19

Shots: The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states Opinion was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where…

ByDipanshu DixitFebruary 26, 2026

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argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

Shots: argenx has reported P-III (ADAPT OCULUS) trial data on Vyvgart (efgartigimod alfa & hyaluronidase-qvfc; SC PFS) in adults with ocular MG, where Part A randomized pts to Vyvgart (QW × 4) or PBO PH20 SC with 4wk. follow-up, & Part B provided 2 cycles of 4 QW injections separated by a 4wk. interval Trial…

ByRidhi RastogiFebruary 26, 2026

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Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

Shots: The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…

ByRidhi RastogiFebruary 25, 2026

NEWS

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

Shots: FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…

ByRidhi RastogiFebruary 25, 2026

NEWS

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Shots: The US FDA has received an sBLA of Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial achieved stringent 1EP of a durable hemoglobin response & showed…

ByRidhi RastogiFebruary 25, 2026

NEWS

Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D

Shots: The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026 Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from…

ByRidhi RastogiFebruary 24, 2026

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Novartis Reports the CHMP Positive Opinion for Remibrutinib for Chronic Spontaneous Urticaria (CSU)

Moderna’s mCOMBRIAX Receives the CHMP Positive Opinion to Protect Against Influenza and COVID-19

argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D

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