Blog
RSS FeedPosted by Michael Wonder on 05 Nov 2025
Advicenne has submitted to US FDA the registration application for Sibnayal in dRTA treatment
4 November 2025 - Advicenne announces the submission of the registration application for Sibnayal (fixed-dose combination of potassium citrate and ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...
Posted by Michael Wonder on 04 Nov 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010
3 November 2025 - Outlook Therapeutics today announced it has resubmitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 03 Nov 2025
Viridian Therapeutics announces successful October submission of biologics license application to US FDA for veligrotug in thyroid eye disease
3 November 2025 - Viridian Therapeutics today announced the successful October submission of its biologics license application to the US FDA ...
Posted by Michael Wonder on 03 Nov 2025
US FDA approves Kygevvi (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency
3 November 2025 - UCB today announced that Kygevvi has been granted approval by the US FDA for the treatment ...
Posted by Michael Wonder on 01 Nov 2025
Johnson & Johnson submits application to US FDA for Stelara (ustekinumab) in the treatment of paediatric ulcerative colitis
31 October 2025 - Expanded Stelara indication seeks to treat children two years of age and older with moderately to severely ...
Posted by Michael Wonder on 29 Oct 2025
Enigma Biomedical USA announces FDA acceptance of new drug application for florquinitau F-18 (MK-6240), a tau PET Alzheimer’s disease radiodiagnostic
28 October 2025 - Enigma Biomedical today announced that the FDA has accepted a new drug application for MK-6240 (florquinitau F-18), ...
Posted by Michael Wonder on 25 Oct 2025
Receipt of complete response ketter from US FDA for investigational ND0612
23 October 2025 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 24 Oct 2025
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for certain patients with muscle-invasive bladder cancer
23 October 2025 - Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the ...
Posted by Michael Wonder on 23 Oct 2025
Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer
21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced ...
Posted by Michael Wonder on 22 Oct 2025
Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program
20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 21 Oct 2025
Replimune announces FDA acceptance of BLA resubmission of RP1 for the treatment of advanced melanoma
20 October 2025 - Replimune today announced that the US FDA has accepted the resubmission of the biologics license application for ...
Posted by Michael Wonder on 21 Oct 2025
FDA awards first ever national priority vouchers to nine sponsors
16 October 2025 - The US FDA today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot ...
Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics ...
Posted by Michael Wonder on 16 Oct 2025
FDA accepts Cingulate’s new drug application for CTx-1301 in attention deficit hyperactivity disorder and sets a 31 May 2026 PDUFA date
14 October 2025 - Cingulate today announced that the US FDA has accepted for review the new drug application for CTx-1301 ...