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RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Jan 2026
FDA grants regenerative medicine advanced therapy designation to iRegene's NouvNeu001, making it the world's first iPSC therapy with both FTD and RMAT recognitions
19 January 2026 - iRegene Therapeutics today announced that its lead product, NouvNeu001, has been granted regenerative medicine advanced therapy ...
Posted by Michael Wonder on 17 Jan 2026
Some drugmakers quietly concerned about legal risk with speedy FDA review program
16 January 2026 - More than half a dozen major drug makers are participating in the Trump Administration's speedier review ...
Posted by Michael Wonder on 17 Jan 2026
US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
15 January 2026 - The US FDA has delayed reviews of two drugs chosen for the Trump Administration's new fast ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 08 Jan 2026
Vera Therapeutics announces US FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy
7 January 2026 - Vera Therapeutics today announced the atacicept biologics license application for the treatment of adults with immunoglobulin A ...
Posted by Michael Wonder on 23 Dec 2025
Viridian Therapeutics announces BLA acceptance and priority review for veligrotug for the treatment of thyroid eye disease
22 December 2025 - PDUFA target action date of 30 June 2026. ...
Posted by Michael Wonder on 20 Dec 2025
FDA grants two national priority vouchers
19 December 2025 - The US FDA today awarded national priority vouchers under the Commissioner’s National Priority Voucher pilot program ...
Posted by Michael Wonder on 16 Dec 2025
Tecvayli and Darzalex Faspro combination selected for Commissioner’s National Priority Voucher Pilot program
15 December 2025 - We are pleased the US FDA has selected the teclistamab MajesTEC-3 supplemental biologics license application to participate ...
Posted by Michael Wonder on 11 Dec 2025
US FDA grants priority review to Bristol Myers Squibb's application for Opdivo (nivolumab) plus chemotherapy combination for classical Hodgkin's lymphoma
11 December 2025 - Bristol Myers Squibb today announced that the US FDA has accepted and granted priority review to ...
Posted by Michael Wonder on 10 Dec 2025
Senti Bio receives FDA regenerative medicine advanced therapy designation for SENTI-202 in the treatment of adults with relapsed or refractory acute myeloid leukaemia
9 December 2025 - Senti Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 08 Dec 2025
House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
2 December 2025 - The US House of Representatives has passed a new piece of legislation that reauthorises the US ...
Posted by Michael Wonder on 02 Dec 2025
Baxdrostat new drug application accepted under FDA priority review in the US for patients with hard to control hypertension
2 December 2025 - Submission based on positive BaxHTN Phase 3 trial results which demonstrated statistically significant and clinically meaningful reduction ...