Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 01 Mar 2026
New PBS listing for immunotherapy cancer drugs Opdivo and Yervoy to be slashed
2 March 2026 - Patients with advanced and rare cancers will be able to access two immunotherapy drugs for just $25, ...
Posted by Michael Wonder on 01 Mar 2026
Eton Pharmaceuticals announces US FDA approval for Desmoda (desmopressin acetate) oral solution
25 February 2026 - Commercial launch expected on 9 March 2026. ...
Posted by Michael Wonder on 01 Mar 2026
US FDA approves BioMarin’s Palynziq (pegvaliase-pqpz) for adolescents 12 years of age and older with phenylketonuria
27 February 2026 - BioMarin today announced that the US FDA has approved the company's supplemental biologics license application for Palynziq ...
Posted by Michael Wonder on 28 Feb 2026
Highlights from the 23-26 February 2026 CHMP meeting
27 February 2026 - The EMA’s CHMP has recommended 12 medicines for approval at its February 2026 meeting. ...
Posted by Michael Wonder on 28 Feb 2026
Asieris announces EMA accepts marketing authorisation application for APL-1702
27 February 2026 - Asieris Pharmaceuticals announced today that its marketing authorisation application for APL-1702 (Cevira) for the treatment of high ...
Posted by Michael Wonder on 28 Feb 2026
Photocure partner Asieris announces that EMA has accepted marketing authorisation application for Cevira in Europe
27 February 2026 - Photocure announces that its partner Asieris Pharmaceuticals communicated today that its marketing authorisation application for Cevira (APL-1702) ...
Posted by Michael Wonder on 28 Feb 2026
Pendopharm announces the commercialisation of Buccolam in Canada
27 February 2026 - Pendopharm is pleased to announce that Buccolam is now available in Canada. ...
Posted by Michael Wonder on 28 Feb 2026
Switzerland’s bitter sweet news for Alzheimer’s patients
27 February 2026 - Swiss medicines regulator Swissmedic was expected to approve two drugs for Alzheimer‘s disease. ...
Posted by Michael Wonder on 28 Feb 2026
Ontario becomes the first province to publicly reimburse the first targeted oral therapy for adults with grade 2 IDH-mutant glioma
27 February 2026 - Servier Canada announces Ontario coverage of Voranigo under the FAST program. ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications
27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...
Posted by Michael Wonder on 28 Feb 2026
Opus Genetics announces FDA acceptance of supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia
25 February 2026 - Opus Genetics today announced that the US FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 27 Feb 2026
Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata
27 February 2026 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for Olumiant ...
Posted by Michael Wonder on 27 Feb 2026
Dupixent (dupilumab) recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment
27 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the EMA’s CHMP adopted a positive opinion recommending the approval ...
Posted by Michael Wonder on 27 Feb 2026
Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria
27 February 2026 - Novartis announced today that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...