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RSS FeedPosted by Michael Wonder on 10 Jun 2026
Matisse Pharmaceuticals receives FDA fast track designation for isupartob sodium in sepsis
9 June 2026 - Matisse Pharmaceuticals today announced that the US FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 10 Jun 2026
Chiesi Global Rare Diseases announces Health Canada grants priority review for Filsuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
9 June 2026 - Chiesi Global Rare Diseases today announced that Health Canada has accepted the new drug submission for Filzuvez ...
Posted by Michael Wonder on 10 Jun 2026
Nucala (mepolizumab) approved in Canada for use in adults with chronic obstructive pulmonary disease
9 June 2026 - GSK announced today that Health Canada has approved Nucala (mepolizumab) as an add-on maintenance treatment in ...
Posted by Michael Wonder on 10 Jun 2026
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate to severe atopic dermatitis
9 June 2026 - Eli Lilly announced today that the US FDA approved a regimen of one maintenance dose every eight ...
Posted by Michael Wonder on 09 Jun 2026
US FDA accepts Takeda's application for intravenous Entyvio (vedolizumab) in paediatric ulcerative colitis and Crohn's disease
9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous ...
Posted by Michael Wonder on 09 Jun 2026
Health Canada authorizes Lunsumio (mosunetuzumab) for the treatment of relapsed or refractory follicular lymphoma after two or more systemic therapies
8 June 2026 - Roche Canada is pleased to announce that Health Canada has granted market authorisations for Lunsumio (mosunetuzumab ...
Posted by Michael Wonder on 09 Jun 2026
New progress toward public reimbursement of Skyclarys for people living with Friedreich ataxia in Quebec
8 June 2026 - Biogen is pleased to announce a positive outcome from the Institut national d'excellence en santé et en ...
Posted by Michael Wonder on 09 Jun 2026
Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector
8 June 2026 - The European Commission has approved Sarclisa (isatuximab) subcutaneous in combination with standard of care regimens for the ...
Posted by Michael Wonder on 09 Jun 2026
Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio
8 June 2026 - Alvotech today announced that the US FDA has accepted for review a biologics license application for ...
Posted by Michael Wonder on 08 Jun 2026
US FDA approves Pfizer’s Hympavzi for the treatment of two additional haemophilia A or B patient populations with significant medical need
8 June 2026 - Pfizer today announced that the US FDA has approved an expanded indication for Hympavzi (marstacimab-hncq) to include ...
Posted by Michael Wonder on 08 Jun 2026
ICER publishes final evidence report on treatment for narcolepsy
8 June 2026 - The ICER today released a final evidence report assessing the comparative clinical effectiveness and value of ...
Posted by Michael Wonder on 08 Jun 2026
Eli Lilly savages Australia’s health subsidies in its standoff over weight loss and diabetes drug
7 June 2026 - Pharmaceutical giant Eli Lilly has delivered a scathing critique of Australia’s medicines subsidy process, saying the ...
Posted by Michael Wonder on 07 Jun 2026
Boan Biotech submits a biologics license application for two denosumab biosimilars in the US
29 May 2026 - Boan Biotech announced today that it has submitted a biologics license application to the US FDA for ...
Posted by Michael Wonder on 06 Jun 2026
Xspray Pharma receives CRL from US FDA for Nilopki
4 June 2026 - Xspray Pharma has received a complete response letter from the US FDA for its new drug application ...
Posted by Michael Wonder on 06 Jun 2026
Chiesi Global Rare Diseases announces European Commission approval of Lojuxta (lomitapide) capsules for paediatric use in homozygous familial hypercholesterolaemia
5 June 2026 - Chiesi Global Rare Diseases today announced that the European Commission has approved lomitapide capsules for use in ...