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 05 Jun 2024
Quince Therapeutics receives US FDA fast track designation for EryDex system
3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...
Posted by Michael Wonder on 05 Jun 2024
Telix completes TLX250-CDx (Zircaix) BLA submission for kidney cancer imaging
3 June 2024 - Telix today announces that it has completed the submission of a biologics license application to the ...
Posted by Michael Wonder on 05 Jun 2024
Nidlegy marketing authorisation application submitted to EMA
4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...
Posted by Michael Wonder on 05 Jun 2024
Rinvoq (upadacitinib) now available for paediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis
4 June 2024 - First indications of Rinvoq (upadacitinib) for paediatric patients two years of age and older. ...
Posted by Michael Wonder on 04 Jun 2024
Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections
31 May 2024 - Oral sulopenem NDA has been assigned a PDUFA action date of 25 October 2024. ...
Posted by Michael Wonder on 04 Jun 2024
CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
Posted by Michael Wonder on 04 Jun 2024
Repare Therapeutics announces fast track designation granted by the FDA for lunresertib in combination with camonsertib for the treatment of platinum resistant ovarian cancer
4 June 2024 - Repare Therapeutics today announced the US FDA has granted fast track designation to lunresertib in combination with ...
Posted by Michael Wonder on 04 Jun 2024
Mounjaro is second obesity drug to be approved for use in England
4 June 2024 - Those with BMI of at least 35 kg.m2 and a co-morbidity can now be prescribed tirzepatide and ...
Posted by Michael Wonder on 03 Jun 2024
Paediatric rare disease drug Qarziba gets green light for coverage
30 May 2024 - The Health Insurance Review and Assessment Service (HIRA) held its fourth Cancer Disease Review Committee (CDRC) ...
Posted by Michael Wonder on 03 Jun 2024
Bavarian Nordic submits supplemental BLA seeking US FDA approval of freeze dried formulation of smallpox and mpox vaccine
31 May 2024 - Bavarian Nordic today announced the submission of a supplemental biologics license application to the US FDA ...
Posted by Michael Wonder on 03 Jun 2024
Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS
30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...
Posted by Michael Wonder on 03 Jun 2024
New pharmacy agreement delivers cheaper medicines
3 June 2024 - The Albanese Government and the Pharmacy Guild of Australia have signed the eighth Community Pharmacy Agreement ...
Posted by Michael Wonder on 03 Jun 2024
Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 03 Jun 2024
Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation
31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action ...