Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Aug 2025
Dawnzera (donidalorsen) approved in the US as first and only RNA targeted prophylactic treatment for hereditary angioedema
21 August 2025 - Offers longest dosing option for hereditary angioedema, with dosing every 4 or 8 weeks. ...
Posted by Michael Wonder on 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...
Posted by Michael Wonder on 21 Aug 2025
BioAegis Therapeutics awarded second FDA fast track designation for recombinant human gelsolin to treat inflammasome driven decompression sickness
20 August 2025 - Second fast rrack designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven ...
Posted by Michael Wonder on 20 Aug 2025
Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer
18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based ...
Posted by Michael Wonder on 20 Aug 2025
Eylea HD (aflibercept) injection 8 mg applications for expanded US label and pre-filled syringe receive FDA review period extension
20 August 2025 - Regeneron Pharmaceuticals today announced that the US FDA has extended the target action dates to the fourth ...
Posted by Michael Wonder on 20 Aug 2025
Aldeyra Therapeutics receives fast track designation for ADX‑2191 for the treatment of retinitis pigmentosa
19 August 2025 - 025-- Aldeyra Therapeutics today announced that the US FDA has granted fast track designation for ADX-2191 (methotrexate ...
Posted by Michael Wonder on 20 Aug 2025
PTC Therapeutics receives complete response letter for vatiquinone NDA
19 August 2025 - PTC Therapeutics announced today that the US FDA has issued a complete response letter related to ...