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 25 Jun 2021
Vericiguat approved in Japan to treat patients with chronic heart failure
23 June 2021 - Heart failure affects approximately 1.2 million people in Japan. ...
Posted by Michael Wonder on 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 24 Jun 2021
PMPRB risks harming the health of Canadians by reducing access to new medicines
23 June 2021 - On June 21, Innovative Medicines Canada submitted six recommendations to the federal government as part of the ...
Posted by Michael Wonder on 24 Jun 2021
Evrysdi approved in Japan for the treatment of spinal muscular atrophy
23 June 2021 - 48th country that approved Evrysdi. ...
Posted by Michael Wonder on 24 Jun 2021
Teva announces Ministry of Health, Labour and Welfare approves Ajovy (fremanezumab) injection in Japan for the preventive treatment of migraine in adults
23 June 2021 - Ajovy developed by Otsuka in Japan through exclusive license agreement. ...
Posted by Michael Wonder on 24 Jun 2021
Alnylam announces U.S. FDA acceptance of new drug application for investigational vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis
24 June 2021 - PDUFA date set for 14 April 2022. ...
Posted by Michael Wonder on 24 Jun 2021
Biogen expects slow Alzheimer’s drug uptake, may reset price
24 June 2021 - Company faces uproar over $56,000 a year price tag for Aduhelm. ...
Posted by Michael Wonder on 24 Jun 2021
Santen receives FDA approval for Verkazia (cyclosporin 0.1% ophthalmic emulsion) for the treatment of vernal keratoconjunctivitis in children and adults
24 June 2021 - Santen today announced that the U.S. FDA has approved Verkazia (cyclosporin 0.1% ophthalmic emulsion eye drops) for ...
Posted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...
Posted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), ...
Posted by Michael Wonder on 24 Jun 2021
FDA accepts application for Genentech’s port delivery system with ranibizumab for treatment of wet age related macular degeneration
24 June 2021 - If approved, PDS would be the first and only eye implant with continuous drug delivery that offers ...
Posted by Michael Wonder on 24 Jun 2021
China's first CAR-T cell therapy approved Fosun Kite axicabtagene ciloleucel (FKC876)
24 June 2021 - The first CAR-T cell therapy approved by NMPA: opening a new era of cell therapy in China. ...
Posted by Michael Wonder on 24 Jun 2021
Anticancer agent Tazverik 200 mg tablets (tazemetostat hydrobromide) approved in Japan for EZH2 gene mutation positive follicular lymphoma
23 June 2021 - Eisai announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor Tazverik ...
Posted by Michael Wonder on 24 Jun 2021
Lynparza approved in China for the treatment of BRCA mutated metastatic castration resistant prostate cancer
24 June 2021 - First PARP inhibitor approved in China in advanced prostate cancer. ...
Posted by Michael Wonder on 24 Jun 2021
Moving patient stories highlight opportunities to strengthen our health care systems for all Australians
24 June 2021 - It was an emotional evening among the nearly 200 in-person and online attendees at Parliament House last ...