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 07 Sep 2022
FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...
Posted by Michael Wonder on 07 Sep 2022
Tarsus submits new drug application to the FDA for TP-03 for the treatment of demodex blepharitis
7 September 2022 - Tarsus Pharmaceuticals today announced that it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 07 Sep 2022
Rhythm Pharmaceuticals announces Imcivree (setmelanotide) granted marketing authorisation by European Commission for treatment of obesity and control of hunger in Bardet-Biedl syndrome
6 September 2022 - Setmelanotide now FDA approved and EC authorized for Bardet-Biedl syndrome. ...
Posted by Michael Wonder on 07 Sep 2022
QOL Medical receives FDA approval of Sucraid (sacrosidase) oral solution single-use containers for patients with congenital sucrase-isomaltase deficiency
6 September 2022 - QOL Medical announced today that the US FDA approved Sucraid single-use containers for patients more than 33 ...
Posted by Michael Wonder on 07 Sep 2022
Blood cancer patients implore PHARMAC to fund desperately needed medicine
7 September 2022 - New Zealanders living with multiple myeloma are mounting a major, evidence-based campaign to press PHARMAC into funding ...
Posted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 07 Sep 2022
First combination COVID-19 and influenza self-tests approved for Australia
7 September 2022 - The TGA has approved the first two nasal combination self-tests (for use at home) that detect ...
Posted by Michael Wonder on 07 Sep 2022
Cheaper scripts for millions
7 September 2022 - For the first time in its 75 year history, the maximum cost of general scripts under ...
Posted by Michael Wonder on 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
Posted by Michael Wonder on 06 Sep 2022
InnoCare announces priority review of orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma by NMPA
6 September 2022 - InnoCare Pharma announced today that BTK inhibitor orelabrutinib has been granted priority review for the treatment of ...
Posted by Michael Wonder on 06 Sep 2022
Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
6 September 2022 - Phase 3 trial results show Onureg offers significantly longer overall and relapse-free survival. ...
Posted by Michael Wonder on 06 Sep 2022
ICR criticises NICE rejection of olaparib for advanced prostate cancer
6 September 2022 - The Institute of Cancer Research, London, has expressed disappointment that NICE has confirmed its decision not ...
Posted by Michael Wonder on 06 Sep 2022
ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
6 September 2022 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 06 Sep 2022
Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend (pegfilgrastim-fpgk)
6 September 2022 - Fresenius Kabi’s first approved U.S. biosimilar. ...
Posted by Michael Wonder on 06 Sep 2022
Italian Medicines Agency approves reimbursed access to Bylvay (odevixibat) for patients with all PFIC types
6 September 2022 - Positive Agenzia Italiana del Farmaco (AIFA) decision provides reimbursed access to the first medicine available for the ...