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RSS FeedPosted by Michael Wonder on 17 Mar 2026
Sun Pharma announces US FDA acceptance of supplemental biologics license application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis
16 March 2026 - Sun Pharmaceutical Industries announced that the US FDA has accepted for review the supplemental biologics license ...
Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical ...
Posted by Michael Wonder on 16 Mar 2026
Telix resubmits NDA to US FDA for TLX101-Px (Pixclara) brain cancer imaging candidate
16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 11 Mar 2026
Capricor Therapeutics announces establishment of new PDUFA date for deramiocel BLA
10 March 2026 - Capricor Therapeutics today announced that the US FDA has lifted the previously issued complete response letter ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease following agency review of additional data
9 March 2026 - ImmunityBio today announced that the US FDA has acknowledged receipt of its supplemental biologics license application ...
Posted by Michael Wonder on 09 Mar 2026
Enhertu granted priority review in the US as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
9 March 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 07 Mar 2026
US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis
6 March 2026 - Significantly more patients treated with once daily, oral Sotyktu achieved an ACR20 response compared with placebo at ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...
Posted by Michael Wonder on 05 Mar 2026
Priovant announces FDA acceptance and priority review of new drug application for brepocitinib in dermatomyositis
3 March 2026 - Priovant Therapeutics today announced that the US FDA has accepted its new drug application for brepocitinib for ...
Posted by Michael Wonder on 02 Mar 2026
Takeda and Protagonist announce US FDA accepts new drug application and grants priority review for rusfertide as a potential first in class therapy for polycythemia vera
2 March 2026 - Takeda and Protagonist Therapeutics today announced that the US FDA accepted the new drug application and granted ...
Posted by Michael Wonder on 02 Mar 2026
FDA accepts Viatris supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia
25 February 2026 - Viatris today announced that the US FDA has accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...
Posted by Michael Wonder on 28 Feb 2026
Opus Genetics announces FDA acceptance of supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia
25 February 2026 - Opus Genetics today announced that the US FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 27 Feb 2026
Xspray Pharma resubmits its FDA application for Dasynoc
26 February 2026 - Xspray Pharma has resubmitted its application for market approval for Dasynoc to the US FDA. ...