Blog
RSS FeedPosted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...
Posted by Michael Wonder on 03 Sep 2025
Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license ...
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 26 Aug 2025
European Commission authorises twice yearly Yeytuo (lenacapavir) for HIV prevention
26 August 2025 - Accelerated EC decision comes after US FDA approval in June. ...
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 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 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
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 ...
Posted by Michael Wonder on 19 Aug 2025
NewAmsterdam announces acceptance of marketing authorisation applications for review by EMA for obicetrapib
18 August 2025 - NewAmsterdam Pharma today announced that the EMA has validated the marketing authorisation application for obicetrapib 10 mg ...
Posted by Michael Wonder on 19 Aug 2025
Ultragenyx initiates rolling submission of niologics license application to US FDA for DTX401 AAV gene therapy for the Treatment of glycogen storage disease type Ia
18 August 2025 - Ultragenyx today announced the initiation of a rolling submission of a niologics license application to the US ...
Posted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application ...