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RSS FeedPosted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...
Posted by Michael Wonder on 27 Jan 2026
MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections or insulin pump mealtime therapy
26 January 2026 - Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions. ...
Posted by Michael Wonder on 26 Jan 2026
Cogent Biosciences announces breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours
26 January 2026 - Cogent will submit the PEAK new drug application under previously announced RTOR designation; on track to complete ...
Posted by Michael Wonder on 23 Jan 2026
Minimal residual disease and complete response in multiple myeloma: use as outcomes to support accelerated approval
20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 22 Jan 2026
BioNTech receives FDA fast track designation for mRNA cancer immunotherapy candidate BNT113 in HPV16+ head and neck cancer
21 January 2026 - BioNTech today announced that the US FDA has granted fast track designation to BNT113, an investigational mRNA ...
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 21 Jan 2026
Scynexis receives FDA qualified infectious disease product and fast track designations for SCY-247
21 January 2026 - Scynexis today announced that the US FDA has granted the Company qualified infectious disease product and fast ...
Posted by Michael Wonder on 21 Jan 2026
US FDA grants to Wugen’s WU-CART-007 breakthrough therapy designation for treatment of relapsed or refractory T cell acute lymphoblastic leukaemia / T cell lymphoblastic lymphoma
21 January 2026 - Wugen today announced that it has received breakthrough therapy designation from the US FDA for its ...
Posted by Michael Wonder on 21 Jan 2026
BioXcel Therapeutics submits supplemental new drug application to US FDA for Igalmi label expansion in the at home setting
20 January 2026 - BioXcel Therapeutics today announced it submitted a supplemental new drug application to the US FDA for the ...
Posted by Michael Wonder on 21 Jan 2026
LBL-024 (opamtistomig PD-L1/4-1BB bispecific antibody) granted fast track designation by the US FDA
14 January 2026 - The Company is pleased to announce that LBL-024 (opamtistomig), a PD-L1/4-1BB bispecific antibody, was granted fast ...
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
Ouro Medicines receives US FDA fast track designation for gamgertamig in immune thrombocytopenia and auto-immune haemolytic anaemia
20 January 2026 - Ouro Medicines today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody investigational candidate, has ...
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 20 Jan 2026
Lilly's sofetabart mipitecan receives US FDA's breakthrough therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer
20 January 2025 - Eli Lilly and Company today announced that the US FDA has granted breakthrough therapy designation to sofetabart ...