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RSS FeedPosted 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 31 Aug 2025
Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2
27 August 2025 - Moderna today announced that the US FDA has approved the supplemental biologics license applications for the ...
Posted by Michael Wonder on 31 Aug 2025
Pfizer and BioNTech’s Comirnaty receives US FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19
27 August 2025 - The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sub-lineage LP.8.1, in line with FDA guidance to more ...
Posted 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 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
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 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
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 ...