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 28 Feb 2022
AbbVie seeks new indication for Imbruvica (ibrutinib) in paediatric patients with chronic graft versus host disease
28 February 2022 - The sNDA and NDA submissions were primarily based on results of three years of data from ...
Posted by Michael Wonder on 28 Feb 2022
Amryt receives complete response letter from the FDA for Oleogel-S10 NDA
28 February 2022 - Amryt receives complete response letter from the FDA for Oleogel-S10 NDA. ...
Posted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the EMA has confirmed its previously ...
Posted by Michael Wonder on 28 Feb 2022
New Zealand Pharmaceutical Schedule - 1 March 2022
1 March 2022 - The March 2022 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 28 Feb 2022
Lagevrio (molnupiravir) PBS listing
1 March 2022 - Commencing 1 March 2022, Lagevrio (molnupiravir) will be listed on the PBS Section 85 program as an ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
25 February 2022 - Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Schedule of Pharmaceutical Benefits - 1 March 2022
1 March 2022 - The March 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate -648 trial, in which the immunotherapy combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
JW Therapeutics announces NMPA acceptance of the supplemental new drug application for Carteyva in patients with relapsed or refractory follicular lymphoma
27 February 2022 - JW Therapeutics announced that the National Medical Products Administration of China accepted the supplemental new drug ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) as adjuvant treatment for patients with radically resected, high-risk muscle-invasive urothelial carcinoma with tumour cell PD-L1 expression ≥1%
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate-274 trial, in which Opdivo significantly reduced patients’ risk ...
Posted by Michael Wonder on 28 Feb 2022
Amylyx Pharmaceuticals announces EMA validation of marketing authorisation application for AMX0035 for the treatment of ALS
25 February 2022 - Amylyx Pharmaceuticals today announced that its marketing authorisation application to the EMA CHMP for AMX0035 (sodium phenylbutyrate ...
Posted by Michael Wonder on 28 Feb 2022
GC Pharma receives complete response letter from the U.S. FDA for Alyglo
27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 28 Feb 2022
ATAGI update following weekly COVID-19 meeting (23 February 2022)
28 February 2022 - ATAGI recommends Spikevax (Moderna) COVID-19 vaccine can be used for primary vaccination in children aged 6-11 ...
Posted by Michael Wonder on 28 Feb 2022
PHARMAC ensures earlier access to key COVID-19 treatment
28 February 2022 - The access criteria for remdesivir is being temporarily widened to allow hospitals to treat those with ...
Posted by Michael Wonder on 28 Feb 2022
Prescription medicines: applications under evaluation (February 2022)
25 February 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...