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Eli lilly
NEWS

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots:The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriersApproval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD ptsThe TRAILBLAZER-ALZ 2 trial showed…
September 26, 2025

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Takeda
NEWS

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots:FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric ptsApproval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…
September 8, 2025

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NEWS

GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots:The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & JapanSubmission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 2025

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GSK New
NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots:Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

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Novartis
NEWS

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots:Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…
June 12, 2025

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