Blog
RSS FeedPosted by Michael Wonder on 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 04 Sep 2025
Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation
3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for ...
Posted by Michael Wonder on 03 Sep 2025
Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ...
Posted 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 03 Sep 2025
Health Canada approves Elahere for certain types of platinum-resistant ovarian cancers
2 September 2025 - Elahere received approval through Health Canada's priority review process, based on data from the pivotal MIRASOL Phase ...
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
European Commission approves Tevimbra as neo-adjuvant/adjuvant NSCLC treatment
27 August 2025 - Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in peri-operative setting in resectable non-small cell lung ...
Posted by Michael Wonder on 28 Aug 2025
MHRA approves UK’s first new type of antibiotic for urinary tract infections in nearly 30 years
28 August 2025 - The MHRA has approved gepotidacin (Blujepa), a new kind of oral antibiotic pill to treat uncomplicated urinary ...
Posted by Michael Wonder on 28 Aug 2025
MHRA approves zuranolone to treat postnatal depression in adults following childbirth
27 August 2025 - The MHRA has approved zuranolone (Zurzuvae) to treat moderate or severe postnatal depression in adults following childbirth. ...
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. ...