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RSS FeedPosted by Michael Wonder on 04 Feb 2026
OS Therapies initiates US FDA BLA filing for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma
2 February 2026 - OS Therapies today announced that it has formally initiated a biologics license application submission to the US ...
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
Acadia Pharmaceuticals provides update on regulatory submission for trofinetide for the treatment of Rett syndrome in the European Union
2 February 2026 - Acadia Pharmaceuticals today announced that the Company was informed by the CHMP of the EMA of a ...
Posted by Michael Wonder on 03 Feb 2026
Exelixis announces US FDA accepted the new drug application for zanzalintinib in combination with an immune checkpoint inhibitor for patients with metastatic colorectal cancer
2 February 2026 - Exelixis today announced that its new drug application for zanzalintinib, in combination with atezolizumab (Tecentriq), has ...
Posted by Michael Wonder on 03 Feb 2026
Galderma announces US FDA acceptance of relabotulinumtoxinA biologics license application resubmission
2 February 2026 - Galderma today announced that the US FDA has accepted the BLA resubmission for relabotulinumtoxinA for the temporary ...
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 03 Feb 2026
Datroway granted priority review in the US as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy
3 February 2026 - Daiichi Sankyo and AstraZeneca’s supplemental biologics license application for Datroway (datopotamab deruxtecan-dlnk) has been accepted and ...
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
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 30 Jan 2026
Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma
30 January 2026 - Elevar Therapeutics today announced the US FDA accepted the resubmission of a new drug application for its ...
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 ...
Posted by Michael Wonder on 29 Jan 2026
Summit Therapeutics announces US FDA acceptance of biologics license application seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy
29 January 2026 - Summit Therapeutics today announced that the US FDA has accepted for filing Summit's biologics license application seeking ...