Blog
RSS FeedPosted by Michael Wonder on 18 Mar 2026
EMA grants PRIME designation to TolerogenixX’s MIC-Lx therapy for donor-specific immune tolerance in kidney transplantation
11 March 2026 - TolerogenixX today announced that the EMA has granted PRIority MEdicines (PRIME) designation to its lead cell ...
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 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 04 Mar 2026
SpliSense granted EMA EARLY PRIME designation for SPL84 in cystic fibrosis
3 March 2026 - SpliSense today announced that the EMA has granted early Priority Medicines (e-PRIME) designation to SPL84 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 24 Feb 2026
Armata Pharmaceuticals receives FDA Qualified Infectious Disease Product designation for AP-SA02
23 February 2026 - Armata Pharmaceuticals today announced that the US FDA has granted AP-SA02, the Company's Staphylococcus aureus ("S. aureus") ...
Posted by Michael Wonder on 23 Feb 2026
Beren Therapeutics announces FDA acceptance of its new drug application for adrabetadex in infantile-onset Niemann-Pick disease type C
23 February 2026 - Beren Therapeutics today announced that the US FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 19 Feb 2026
Garetosmab biologics license application accepted for FDA priority review for the treatment of fibrodysplasia ossificans progressiva
19 February 2026 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 10 Feb 2026
US FDA accepts new drug application and grants priority review for Takeda’s oveporexton (TAK-861) as a potential first in class therapy for narcolepsy type 1
10 February 2026 - Takeda today announced that the US FDA accepted its new drug application and granted priority review for ...
Posted by Michael Wonder on 09 Feb 2026
Krystal Biotech announces RMAT designation granted by FDA to KB707 for the treatment of advanced or metastatic non-small cell lung cancer
9 February 2026 - Krystal Biotech announced today that the US FDA granted regenerative medicine advanced therapy designation to KB707, ...
Posted by Michael Wonder on 06 Feb 2026
FDA grants priority review for Hympavzi (marstacimab) sBLA for the treatment of two haemophilia A or B patient populations with significant medical need
6 February 2026 - Pfizer today announced that the US FDA has accepted and granted priority review for the company’s ...
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 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 21 Jan 2026
iECURE receives FDA regenerative medicine advanced therapy designation for ECUR-506 for neonatal onset ornithine transcarbamylase deficiency
7 January 2026 - iECURE today announced that the US FDA has granted regenerative medicine advanced therapy designation to ECUR-506, ...
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 ...