Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2025
Otsuka and Lundbeck receive complete response letter from US FDA for sNDA of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder
20 September 2025 - Otsuka and Lundbeck) announce that Otsuka has received a Complete Response Letter from the US FDA regarding ...
Posted by Michael Wonder on 21 Sep 2025
First treatment recommended for rare immunoglobulin-related autoimmune disease
19 September 2025 - Uplizna significantly reduced the number of flares in patients with active immunoglobulin G4-related disease. ...
Posted by Michael Wonder on 20 Sep 2025
Highlights from the 15-18 September 2025 CHMP meeting
19 September 2025 - The EMA’s CHMP has recommended 14 medicines for approval at its September 2025 meeting. ...
Posted 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
A new era of dementia treatment is coming. We are not ready.
19 September 2025 - Inequality in accessing new drugs, the high cost of treatment, and underprepared hospital systems: these obstacles to ...
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 20 Sep 2025
Cost barrier emerges for breakthrough Alzheimer’s drug in Australia
19 September 2025 - The first new Alzheimer’s drug approved for use in Australia in 25 years, ticked off by ...
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 ...