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RSS FeedPosted 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
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
Ultragenyx resubmits biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A (MPS IIIA) to US FDA
30 January 2026 - Company expects up to six month review period per FDA guidelines. ...
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 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 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...
Posted by Michael Wonder on 21 Jan 2026
BioXcel Therapeutics submits supplemental new drug application to US FDA for Igalmi label expansion in the at home setting
20 January 2026 - BioXcel Therapeutics today announced it submitted a supplemental new drug application to the US FDA for the ...
Posted by Michael Wonder on 20 Jan 2026
Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
20 January 2026 - Celcuity today announced that the US FDA has accepted for filing its new drug application for gedatolisib ...
Posted by Michael Wonder on 19 Jan 2026
Organon announces US FDA approval of supplemental new drug application extending duration of use of Nexplanon (etonogestrel implant) 68 mg radiopaque
16 January 2026 - Organon announced today that the US FDA has approved a supplemental new drug application for Nexplanon (etonogestrel ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 14 Jan 2026
Travere Therapeutics announces FDA extends review of sNDA for Filspari (sparsentan) in FSGS
13 January 2026 - Travere Therapeutics announced that today the US FDA has extended the review timeline of its supplemental new ...