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RSS FeedPosted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 01 Aug 2025
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
24 July 2025 - PDUFA target action date of 10 January 2026. ...
Posted by Michael Wonder on 30 Jul 2025
Johnson & Johnson files with US FDA to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis
29 July 2025 - Submission is supported by 24 week results from the Phase 3b APEX study in adults with active ...
Posted by Michael Wonder on 29 Jul 2025
AbbVie submits for US FDA approval of combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
29 July 2025 - Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
Posted by Michael Wonder on 26 Jul 2025
Bayer provides regulatory update on elinzanetant in the US
25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the ...
Posted by Michael Wonder on 25 Jul 2025
FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in post-menopausal women
24 July 2025 - Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...
Posted by Michael Wonder on 24 Jul 2025
Leriglitazone marketing authorisation application submitted for treatment of cerebral adrenoleukodystrophy has been validated by EMA
23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...
Posted by Michael Wonder on 23 Jul 2025
Bavarian Nordic receives acceptance from Health Canada for review of the new drug submission for its chikungunya vaccine
22 July 2025 - Bavarian Nordic announced today that Health Canada has accepted for review the Company’s application for licensure ...
Posted by Michael Wonder on 22 Jul 2025
Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma
23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 22 Jul 2025
Johnson & Johnson seeks first icotrokinra US FDA approval aiming to revolutionise treatment paradigm for adults and adolescents with plaque psoriasis
21 July 2025 - Icotrokinra is a first in class investigational targeted oral peptide that selectively blocks the IL-23 receptor. ...
Posted by Michael Wonder on 21 Jul 2025
Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
Posted by Michael Wonder on 19 Jul 2025
Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi
16 July 2025 - Bio-Thera Solutions today announced that the US FDA has accepted its biologics license application for BAT2506, a ...