Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 31 Aug 2025
Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia
29 August 2025 - Approval based on LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and improvements ...
Posted by Michael Wonder on 29 Aug 2025
Tolremo Therapeutics receives two FDA fast track designations for TT125-802 in pretreated, advanced or metastatic NSCLC with either an EGFR or a KRAS G12C mutation
28 August 2025 - – Tolremo Therapeutics today announced that their lead candidate, TT125-802, received two fast track designations from the ...
Posted by Michael Wonder on 28 Aug 2025
D3 Bio announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C mutated cancers
28 August 2025 - D3 Bio today announced that the US FDA has granted a breakthrough therapy designation to D3S-001, the ...
Posted by Michael Wonder on 28 Aug 2025
Telix provides regulatory update on TLX250-CDx
28 August 2025 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 28 Aug 2025
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD
28 August 2025 - Outlook Therapeutics plans to work with FDA to address the Agency’s issues. ...
Posted by Michael Wonder on 27 Aug 2025
Gadoquatrane new drug application accepted for review by US FDA
26 August 2025 - Bayer today announced that a new drug application for its investigational contrast agent gadoquatrane has been accepted ...
Posted by Michael Wonder on 27 Aug 2025
Cereno Scientific granted FDA fast track designation for CS1 in rare disease pulmonary arterial hypertension
26 August 2025 - Cereno Scientific today announced that the US FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational ...
Posted by Michael Wonder on 26 Aug 2025
Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer
26 August 2025 - Allarity Therapeutics today announced that the US FDA has granted fast track designation to stenoparib, its investigational ...
Posted by Michael Wonder on 26 Aug 2025
Repatha now indicated for adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C
25 August 2025 - Amgen today announced that the US FDA has broadened the approved use of Repatha (evolocumab) to include ...
Posted by Michael Wonder on 26 Aug 2025
Ayrmid announces FDA acceptance and priority review for omidubicel for the treatment of severe aplastic anaemia
25 August 2025 - Ayrmid today announced that the US FDA has accepted the Company’s priority review application for omidubicel for ...
Posted by Michael Wonder on 26 Aug 2025
Rusfertide receives breakthrough therapy designation for treatment of erythrocytosis in patients with polycythemia vera
25 August 2025 - Breakthrough therapy designation complements rusfertide's orphan drug and fast track designations, which together confer multiple benefits to ...
Posted by Michael Wonder on 21 Aug 2025
VeonGen Therapeutics receives FDA regenerative medicine advanced therapy designation for VG801 gene therapy for Stargardt disease
21 August 2025 - VeonGen Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to VG801, ...
Posted by Michael Wonder on 21 Aug 2025
Stealth BioTherapeutics announces FDA acceptance of elamipretide NDA resubmission
21 August 2025 - - Stealth BioTherapeutics announced today that the US FDA has accepted for review the resubmission of the ...