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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Oct 2025
Rocket Pharmaceuticals announces FDA acceptance of BLA resubmission of Kresladi for the treatment of severe leukocyte adhesion deficiency-I
14 October 2025 - PDUFA target action date is 28 March 2026. ...
Posted by Michael Wonder on 14 Oct 2025
MannKind announces US FDA accepts for review its supplemental biologics license application for inhaled ansulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes
13 October 2025 - MannKind Corporation today announced that the US FDA has accepted the supplemental biologics license application seeking approval ...
Posted by Michael Wonder on 13 Oct 2025
Denali Therapeutics announces FDA review extension of BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome)
13 October 2025 - Denali Therapeutics today announced that the US FDA has extended its review timeline of the biologics license ...
Posted by Michael Wonder on 08 Oct 2025
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...