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 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 03 Mar 2022
Harpoon Therapeutics receives FDA fast track designation for HPN217
2 March 2022 - Harpoon Therapeutics today announced that the U.S. FDA has granted fast track designation to HPN217, a BCMA ...
Posted by Michael Wonder on 03 Mar 2022
COVID-19 vaccine weekly safety report (3 March 2022)
3 March 2022 - This is the 52nd issue of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 03 Mar 2022
Amneal enters U.S. biosimilars market with approval of Releuko (filgrastim-ayow)
1 March 2022 - First of three Amneal biosimilars expected for U.S. approval and launch in 2022. ...
Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and ...
Posted by Michael Wonder on 03 Mar 2022
FDA approves Kaléo’s naloxone auto-injector 10 mg for the treatment of known or potential exposure to ultra-potent weaponised opioids
2 March 2022 - Product received fast-track designation for military personnel facing the potential threat of exposure to synthetic opioids ...
Posted by Michael Wonder on 03 Mar 2022
Jemperli approved by the TGA
2 March 2022 - Dostarlimab is an anti-programmed cell death protein 1 immunoglobulin G4 humanised monoclonal antibody, derived from a stable ...
Posted by Michael Wonder on 02 Mar 2022
ATAGI recommends Novavax for use as a COVID-19 booster
2 March 2022 - The Australian Technical Advisory Group on Immunisation has recommended the use of the Novavax vaccine as a ...
Posted by Michael Wonder on 02 Mar 2022
Teva Canada welcomes public drug plan reimbursement by Alberta, Saskatchewan, Québec, Veteran Affairs Canada and the non-insured health benefits program for patients prescribed Ajovy (fremanezumab) for the preventive treatment of migraine in adults
2 March 2022 - Public formulary and program coverage makes AJOVY® accessible to more migraine patients across Canada. ...
Posted by Michael Wonder on 02 Mar 2022
BeiGene hits major milestone with first PBS approved cancer treatment
1 March 2022 - BeiGene is welcoming the listing of Brukinsa (zanubrutinib), a targeted treatment for mantle cell lymphoma, an aggressive ...
Posted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...
Posted by Michael Wonder on 02 Mar 2022
Advanced Innovative Partners announces designation for rare paediatric disease drug
1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...
Posted by Michael Wonder on 02 Mar 2022
U.S. law makers seek answers on 'troubling' drug price increases
1 March 2022 - Senators Elizabeth Warren and Amy Klobuchar and 11 other U.S. law makers pressed the president of ...
Posted by Michael Wonder on 02 Mar 2022
Progression-free survival: it is time for a new name
1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...
Posted by Michael Wonder on 02 Mar 2022
Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline
1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...