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RSS FeedPosted by Michael Wonder on 19 Nov 2025
Esperion partner HLS Therapeutics announces approval of Nilemdo for the reduction of LDL-cholesterol in Canadians at risk of cardiovascular disease
18 November 2025 - Esperion today announced that HLS Therapeutics, the Company’s partner in Canada for the development and commercialization ...
Posted by Michael Wonder on 19 Nov 2025
Grifols receives expanded indication for Thrombate III (antithrombin III [human]) label in US, strengthening treatment options for pediatric patients
18 November 2025 - FDA approval was based on submitted data extrapolation from two clinical trials in adult patients addressing critical ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Brinsupri (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union
18 November 2025 - Brinsupri was reviewed under EMA's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 18 Nov 2025
Vasa Therapeutics granted FDA fast track designation for VS-041, a novel investigational treatment of heart failure with preserved ejection fraction
18 November 2025 - Vasa Therapeutics today announced that the US FDA has granted fast track designation to its lead investigational ...
Posted by Michael Wonder on 18 Nov 2025
Arrowhead Pharmaceuticals announces FDA approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
18 November 2025 - The FDA approval is based on positive results from the Phase 3 PALISADE study where Redemplo significantly ...
Posted by Michael Wonder on 18 Nov 2025
FDA approves epcoritamab-bysp for follicular lymphoma indications
18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) with lenalidomide and rituximab for relapsed or refractory follicular ...
Posted by Michael Wonder on 18 Nov 2025
Lupron Depot new strength receives Health Canada approval for the treatment of advanced prostate cancer
17 November 2025 - AbbVie announced today that a new 6 month 45 mg Lupron Depot (leuprolide acetate for extended release ...
Posted by Michael Wonder on 18 Nov 2025
High dose regimen of nusinersen receives positive CHMP opinion for the treatment of spinal muscular atrophy
17 November 2025 - Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen ...
Posted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...
Posted by Michael Wonder on 16 Nov 2025
Ascelia Pharma announces FDA acceptance of Orviglance new drug application for review
15 November 2025 - Ascelia Pharma today announced that the US FDA has accepted the new drug application for Orviglance for ...
Posted by Michael Wonder on 15 Nov 2025
FDA’s new plausible mechanism pathway
12 November 2025 - Personalised therapies hold tremendous promise but challenge traditional models of drug and biologic development. ...
Posted by Michael Wonder on 15 Nov 2025
CHMP positive opinion for Waskyra, a gene therapy for the treatment of Wiskott-Aldrich syndrome
14 November 2025 - Fondazione Telethon announces the positive opinion issued by the CHMP of the EMA, recommending marketing authorisation in ...
Posted by Michael Wonder on 15 Nov 2025
Highlights from the 10-13 November 2025 CHMP meeting
14 November 2025 - The EMA’s CHMP recommended ten medicines for approval at its November 2025 meeting. ...