Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
Posted by Michael Wonder on 29 Jul 2025
Alteogen receives positive CHMP opinion for aflibercept biosimilar, 'Eyluxvi (ALT-L9)'
28 July 2025 - Upon approval, Eyluxvi will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license ...
Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
Posted by Michael Wonder on 29 Jul 2025
FDA approves Apellis’ Empaveli (pegcetacoplan) as the first C3G and primary IC-MPGN treatment for patients 12 and older
28 July 2025 - Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence. ...
Posted by Michael Wonder on 29 Jul 2025
PTC Therapeutics announces FDA approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria
28 July 2025 - Broad labelling inclusive of all disease subtypes for individuals 1 month of age and older. ...
Posted by Michael Wonder on 29 Jul 2025
FDA approves Skytrofa (lonapegsomatropin-tcgd) for the once weekly treatment of adults with growth hormone deficiency
28 July 2025 - On track to initiate basket trial for idiopathic short stature, SHOX deficiency, Turner syndrome, and short ...
Posted by Michael Wonder on 28 Jul 2025
MAIA Biotechnology receives FDA’s fast track designation for ateganosine as a treatment for non-small cell lung cancer
28 July 2025 - Potential first to market small molecule telomere targeting agent targets a $34 billion non-small cell lung cancer ...
Posted by Michael Wonder on 28 Jul 2025
Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastro-oesophageal junction cancers
28 July 2025 - Based on MATTERHORN Phase 3 trial results which demonstrated a statistically significant and clinically meaningful event-free survival ...
Posted by Michael Wonder on 28 Jul 2025
Highlights from the 21-24 July 2025 CHMP meeting
25 July 2025 - The EMA’s CHMP recommended 13 medicines for approval at its July 2025 meeting. ...
Posted by Michael Wonder on 28 Jul 2025
Drug giants targeting Australia’s PBS are paying tiny amounts of tax
28 July 2025 - Global pharmaceutical giants, including Pfizer and Johnson & Johnson, are paying a tiny fraction of the ...
Posted by Michael Wonder on 28 Jul 2025
Government continues to make medicines cheaper
28 July 2025 - The Albanese Government is making cheaper medicines even cheaper – with legislation being introduced to Parliament ...
Posted by Michael Wonder on 28 Jul 2025
Dupilumab for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (review of TA648)
23 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 27 Jul 2025
Vertex announces marketing authorisation in Canada for Alyftrek, a once daily next generation CFTR modulator for the treatment of cystic fibrosis
22 July 2025 - Approximately 3,800 people in Canada are now eligible for Alyftrek, with up to 60 people potentially ...
Posted by Michael Wonder on 26 Jul 2025
Sobi announces US FDA approves Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older with persistent or chronic immune thrombocytopenia
25 July 2025 - The primary outcome was met in 27.8% of patients, confirming the efficacy in children and adolescents ...