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RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Jan 2026
Tenpoint Therapeutics announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia
28 January 2026 - Tenpoint Therapeutics today announced that the US FDA approved Yuvezza (carbachol and brimonidine tartrate ophthalmic solution) ...
Posted by Michael Wonder on 29 Jan 2026
Cipher Pharmaceuticals announces Health Canada's acceptance for review of new drug submission for Natroba (spinosad)
28 January 2026 - Cipher Pharmaceuticals today announced that Health Canada has accepted for review Cipher's new drug submission for ...
Posted by Michael Wonder on 29 Jan 2026
Elevar Therapeutics submits new drug application to FDA for lirafugratinib as second-line treatment option for cholangiocarcinoma
28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 28 Jan 2026
Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults
27 January 2026 - The PDUFA target action date is 24 July 2026. ...
Posted by Michael Wonder on 28 Jan 2026
Novel drug approvals for 2025
23 January 2026 - In 2025, the CDER approved 46 new drugs never before approved or marketed in the US, known ...
Posted by Michael Wonder on 28 Jan 2026
The European Commission extended the marketing authorisation for Vueway (gadopiclenol) in the European Union for use in paediatric patients under 2 years of age
27 January 2026 - Bracco Imaging announces that on 23 January 2026, the European Commission amended the Marketing Authorisation for Vueway ...