Blog
RSS FeedPosted by Michael Wonder on 21 Apr 2026
20 years of priority review vouchers, a tool for spurring needed drugs
19 April 2026 - Occasionally I’ll go watch a TV show taping. Big-name shows are sold out, with long lines ...
Posted by Michael Wonder on 21 Apr 2026
US FDA grants priority review to sBLA for Padcev and Keytruda as peri-operative treatment for muscle invasive bladder cancer regardless of cisplatin eligibility
20 April 2026 - Astellas Pharma and Pfizer announced that the US FDA accepted for triority review a supplemental biologics license ...
Posted by Michael Wonder on 19 Apr 2026
Aicuris receives FDA priority review for pritelivir NDA
16 April 2026 - 26 - Aicuris Anti-infective Cures today announced that the US FDA has granted priority review for the ...
Posted by Michael Wonder on 15 Apr 2026
US FDA grants RMAT designation to GS-100, Grace Science’s gene therapy to treat NGLY1 deficiency
14 April 2026 - Grace Science announced today that the US FDA has granted regenerative medicine advanced therapy designation to GS-100 ...
Posted by Michael Wonder on 13 Apr 2026
Ifinatamab deruxtecan granted priority review in the US for adult patients with previously treated extensive-stage small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy
13 April 2026 - Based on results from IDeate-Lung01 Phase 2 trial, with support from IDeate-PanTumor01 Phase 1/2 trial. ...
Posted by Michael Wonder on 08 Apr 2026
Ray Therapeutics receives FDA regenerative medicine advanced therapy designation for RTx-015 in retinitis pigmentosa
1 April 2026 - Ray Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...
Posted by Michael Wonder on 23 Mar 2026
Ionis announces zilganersen new drug application for Alexander disease accepted by FDA for priority review
23 March 2026 - Ionis Pharmaceuticals today announced that the US FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 19 Mar 2026
FDA approves fourth product under National Priority Voucher Program, higher dose semaglutide
19 March 2026 - The US FDA today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy ...
Posted 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 ...