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RSS FeedPosted by Michael Wonder on 20 Sep 2025
Merck receives two positive EU CHMP opinions for Keytruda (pembrolizumab), for subcutaneous administration and for new indication for earlier-stage head and neck cancer
19 September 2025 - Positive opinion also granted for Keytruda as part of a peri-operative regimen for the treatment of certain ...
Posted by Michael Wonder on 20 Sep 2025
Elinzanetant recommended for approval in EU as treatment of moderate to severe vasomotor symptoms
19 September 2025 - Positive opinion by the CHMP is based on the results from the clinical development Phase 3 studies ...
Posted by Michael Wonder on 20 Sep 2025
CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma
19 September 2025 - Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared ...
Posted by Michael Wonder on 20 Sep 2025
Merck receives positive EU CHMP opinion for Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus in infants during their first RSV season
19 September 2025 - If approved by the European Commission, Enflonsia will be the first and only RSV preventive option ...
Posted by Michael Wonder on 20 Sep 2025
Health Canada approves Celltrion’s Stoboclo and Osenvelt (CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia and Xgeva, respectively
18 September 2025 - The approval is based on the totality of evidence including results from a Phase III clinical ...
Posted by Michael Wonder on 19 Sep 2025
FDA grants accelerated approval to first treatment for Barth syndrome
19 September 2025 - New treatment for Barth syndrome showcases FDA’s commitment to bringing effective and safe medications to patients in ...
Posted by Michael Wonder on 19 Sep 2025
Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2-11 with atopic dermatitis
18 September 2025 - Opzelura is the first topical Janus kinase inhibitor approved in the US for paediatric atopic dermatitis. ...
Posted by Michael Wonder on 19 Sep 2025
Tryngolza (olezarsen) approved in the European Union for familial chylomicronaemia syndrome
19 September 2025 - Sobi and Ionis Pharmaceuticals today announced that Tryngolza (olezarsen) has been approved in the European Union ...
Posted by Michael Wonder on 19 Sep 2025
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
19 September 2025 - Today, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult ...
Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics receives US FDA approval for Bosaya and Aukelso, denosumab biosimilars
17 September 2025 - Biocon Biologics today announced that the US FDA has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous ...
Posted by Michael Wonder on 18 Sep 2025
Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
16 September 2025 - The MHRA has today approved the medicine vorasidenib (Voranigo). ...
Posted by Michael Wonder on 18 Sep 2025
Biogen receives European Commission approval for Zurzuvae (zuranolone), the first and only treatment approved for women with postpartum depression in Europe
17 September 2025 - The EC approval of Zurzuvae is based on the SKYLARK study, which demonstrated rapid relief from depressive ...
Posted by Michael Wonder on 17 Sep 2025
Corstasis Therapeutics announces FDA approval of Enbumyst (bumetanide nasal spray) for the treatment of oedema associated with congestive heart failure, liver disease and kidney disease
15 September 2025 - Enbumyst is the first and only intranasal loop diuretic approved in the US offering a self-administered alternative ...
Posted by Michael Wonder on 15 Sep 2025
EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
15 September 2025 - This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus) reduced ...
Posted by Michael Wonder on 12 Sep 2025
Intercept announces voluntary withdrawal of Ocaliva for primary biliary cholangitis from the US market
11 September 2025 - Intercept Pharmaceuticals today announced its decision to voluntarily withdraw Ocaliva (obeticholic acid) from the US market ...