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RSS FeedPosted by Michael Wonder on 06 Feb 2026
IBSA USA announces FDA approval of Vybrique, the first and only oral film to treat men with erectile dysfunction
5 February 2026 - US commercial availability anticipated in March 2026. ...
Posted by Michael Wonder on 04 Feb 2026
EURneffy 1 mg (adrenaline nasal spray) recommended for approval in the EU for emergency treatment of type 1 allergic reactions, including anaphylaxis in children weighing ≥15 kg to <30 kg
2 February 2026 - ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market EURneffy in the EU, will distribute ...
Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer is pleased to announce that Health Canada has authorized Hyrnuo (sevabertinib), oral tablets, for the treatment ...
Posted by Michael Wonder on 03 Feb 2026
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
3 February 2026 - The US FDA issued a complete response letter regarding the biologics license application for Saphnelo (anifrolumab) for ...
Posted by Michael Wonder on 02 Feb 2026
Donanemab in early Alzheimer's disease: important questions remain unanswered
30 January 2026 - For the treatment of Alzheimer's disease, it is crucial to distinguish between those with mild cognitive ...
Posted by Michael Wonder on 02 Feb 2026
Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm
2 February 2026 - Deficiencies limited to packaging and administration. ...
Posted by Michael Wonder on 02 Feb 2026
Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers
2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...
Posted by Michael Wonder on 02 Feb 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU
30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa. ...
Posted by Michael Wonder on 02 Feb 2026
Pharming Group receives complete response letter from US FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental ...
Posted by Michael Wonder on 01 Feb 2026
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft vs host disease
30 January 2026 - The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in ...
Posted by Michael Wonder on 31 Jan 2026
Cancer patients gain new hope as Keytruda treatment recommended for subsidy under PBS
31 January 2026 - Lifesaving treatment for cancers that now costs tens of thousands of dollars is set to be cut ...
Posted by Michael Wonder on 31 Jan 2026
Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency
30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...
Posted by Michael Wonder on 30 Jan 2026
Recommendations made by the PBAC – December 2025 intracycle meeting
30 January 2026 - The recommendations from the December 2025 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 30 Jan 2026
Highlights from the 26-29 January 2026 CHMP meeting
30 January 2026 - The EMA’s CHMP recommended six medicines for approval at its January 2026 meeting. ...
Posted by Michael Wonder on 30 Jan 2026
Celltrion secures Canadian approval for Omlyclo 300 mg PFS and auto-injector formulations
29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic ...