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RSS FeedPosted by Michael Wonder on 04 Mar 2026
FDA approves first generic of Flovent HFA for treatment of asthma
3 March 2026 - Today, the US FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg/actuation, ...
Posted by Michael Wonder on 03 Mar 2026
Alnylam receives positive recommendation from Canada's Drug Agency for the public reimbursement of Amvuttra (vutrisiran injection), the first and only RNAi therapeutic for the treatment of cardiomyopathy in adult patients with ATTR amyloidosis
2 March 2026 - Alnylam Canada is pleased to announce it has received a positive recommendation from Canada's Drug Agency for ...
Posted by Michael Wonder on 03 Mar 2026
Health Canada Approves Ozempic (semaglutide injection) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
2 March 2026 - Novo Nordisk announced today that Health Canada has approved Ozempic (semaglutide injection) to reduce the risk of ...
Posted by Michael Wonder on 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
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
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
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 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 ...
Posted by Michael Wonder on 26 Feb 2026
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
26 February 2026 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 26 Feb 2026
FDA approves drug for adult and paediatric patients aged 6 and older with allergic fungal rhinosinusitis
25 February 2026 - The US FDA has approved Dupixent (dupilumab) for the treatment of adult and paediatric patients aged 6 ...