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RSS FeedPosted by Michael Wonder on 16 Dec 2024
FDA approves Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
16 December 2024 - In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on Vtama cream ...
Posted by Michael Wonder on 16 Dec 2024
Celltrion receives positive CHMP opinion for three biosimilars in the European Union
15 December 2024 - The CHMP adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...
Posted by Michael Wonder on 14 Dec 2024
Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate to severe atopic dermatitis
13 December 2024 - Galderma today announced that the US FDA has approved Nemluvio (nemolizumab) for the treatment of patients 12 ...
Posted by Michael Wonder on 14 Dec 2024
First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
13 December 2024 - Emcitate can be used in patients of all ages. ...
Posted by Michael Wonder on 14 Dec 2024
First treatment recommended for rare progressive lung conditions in children and adolescents
13 December 2024 - The EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive ...
Posted by Michael Wonder on 14 Dec 2024
First medicine to treat rare genetic disorder causing cysts and tumours
13 December 2024 - Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell ...
Posted by Michael Wonder on 14 Dec 2024
Highlights from the 9-12 December 2024 CHMP meeting
13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting. ...
Posted by Michael Wonder on 14 Dec 2024
Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness
13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...
Posted by Michael Wonder on 14 Dec 2024
FDA approves new treatment for congenital adrenal hyperplasia
13 December 2024 - Today, the US FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids to control androgen levels ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 13 Dec 2024
Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease
13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...
Posted by Michael Wonder on 12 Dec 2024
Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced oesophageal squamous cell cancer
11 December 2024 - NICE is unable to make a recommendation on the use in the NHS of toripalimab (Loqtorzi) in ...
Posted by Michael Wonder on 12 Dec 2024
Merck's Tepmetko, GSK-Janssen's Vocabria+Rekambys combo move closer to reimbursement in Korea
6 December 2024 - Merck's MET inhibitor Tepmetko (tepotinib) has been recognized by the national health insurance reviewer as eligible ...
Posted by Michael Wonder on 12 Dec 2024
Elranatamab for treating relapsed and refractory multiple myeloma after three or more treatments (final guidance)
11 December 2024 - NICE has published final evidence-based recommendations on the use of elranatamab (Elrexfio) for the treatment of ...