Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 04 Oct 2024
Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease
3 October 2024 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for topical ...
Posted by Michael Wonder on 04 Oct 2024
FDA approves neo-adjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
3 October 2024 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neo-adjuvant treatment, followed ...
Posted by Michael Wonder on 03 Oct 2024
Improving efficiency of approval process for new medicines in the EU
2 October 2024 - EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and ...
Posted by Michael Wonder on 03 Oct 2024
Calquence granted priority review in the US for patients with untreated mantle cell lymphoma
3 October 2024 - Submission to be reviewed under Project Orbis. ...
Posted by Michael Wonder on 03 Oct 2024
KalVista announces the submission of additional marketing authorisation applications for sebetralstat for the oral on-demand treatment of hereditary angioedema
30 September 2024 - If approved, sebetralstat will be the first, oral on-demand treatment for HAE. ...
Posted by Michael Wonder on 03 Oct 2024
Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
2 October 2024 - Volastra Therapeutics today announced that the US FDA has granted fast track designation to VLS-1488, the company’s ...
Posted by Michael Wonder on 02 Oct 2024
Securing supply of PrEP
1 October 2024 - The Australian Government is ensuring thousands of Australians, with or at risk of contracting HIV, are ...
Posted by Michael Wonder on 02 Oct 2024
Elacestrant dihydrochloride for the treatment of patients with advanced, oestrogen receptor positive, ESR1 mutation positive, HER2 negative breast cancer after at least one endocrine treatment
1 October 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 02 Oct 2024
NICE ready to work with company to address uncertainty in evidence for elacestrant for advanced breast cancer
1 October 2024 - Today NICE is consulting on draft guidance that does not recommend elacestrant for treating a type of ...
Posted by Michael Wonder on 02 Oct 2024
Johnson & Johnson files for US FDA approval of Darzalex Faspro based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
30 September 2024 - Results from CEPHEUS study highlight Darzalex Faspro quadruplet regimen as a potential standard of care in ...
Posted by Michael Wonder on 02 Oct 2024
Clinuvel files Canadian new drug submission for Scenesse in EPP
30 September 2024 - Patient special access program continues during Health Canada review. ...
Posted by Michael Wonder on 02 Oct 2024
Sagimet receives FDA breakthrough therapy designation for denifanstat in MASH
1 October 2024 - Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH. ...
Posted by Michael Wonder on 02 Oct 2024
Schedule of Pharmaceutical Benefits - 1 October 2024
1 October 2024 - The October 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 02 Oct 2024
Zilganersen granted US FDA fast track designation for people living with Alexander disease
1 October 2024 - Zilganersen is the first investigational medicine in clinical development for adults and children living with Alexander disease, ...
Posted by Michael Wonder on 01 Oct 2024
FDA grants rare paediatric disease designation to MDL-101 for the treatment of congenital muscular dystrophy type 1a
30 September 2024 - Modalis Therapeutics today announced that the US FDA has granted rare paediatric disease designation to MDL-101, a ...