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 16 Sep 2021
COVID-19 vaccine weekly safety report (16 September 2021)
16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...
Posted by Michael Wonder on 16 Sep 2021
Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease
15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...
Posted by Michael Wonder on 16 Sep 2021
PHARMAC funds tocilizumab to treat cases of COVID-19
16 September 2021 - PHARMAC is widening funded access to tocilizumab, an immunosuppressive drug used mainly to treat arthritis, to treat ...
Posted by Michael Wonder on 16 Sep 2021
PHARMAC funds new treatment for rheumatoid arthritis to support people impacted by tocilizumab stock shortage
16 September 2021 - PHARMAC has funded upadacitinib tablets as an alternative treatment for New Zealanders with severe rheumatoid arthritis, ...
Posted by Michael Wonder on 16 Sep 2021
Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC
15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...
Posted by Michael Wonder on 15 Sep 2021
Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA
15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...
Posted by Michael Wonder on 15 Sep 2021
FDA, EMA launch complex generic, hybrid product advice pilot
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...
Posted by Michael Wonder on 15 Sep 2021
Lilly to supply 388,000 doses of etesevimab to U.S. Government for treatment of COVID-19
15 September 2021 - Additional doses of etesevimab will be paired with existing bamlanivimab purchased by the U.S. Government ...
Posted by Michael Wonder on 15 Sep 2021
FDA advances data, IT modernisation efforts with new Office of Digital Transformation
15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...
Posted by Michael Wonder on 15 Sep 2021
Drug prices measure blocked in House Committee as Democrats splinter
15 September 2021 - Provision of $3.5 trillion budget package would allow Medicare to negotiate over the cost of prescriptions. ...
Posted by Michael Wonder on 15 Sep 2021
Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit
15 September 2021 - Third new area of application/those affected still live a good year on average - and thus ...
Posted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...
Posted by Michael Wonder on 15 Sep 2021
NICE backs Opdivo for head and neck cancer
15 September 2021 - NICE has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS ...
Posted by Michael Wonder on 15 Sep 2021
Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...
Posted by Michael Wonder on 15 Sep 2021
ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids
15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and ...