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 18 Dec 2023
GC Biopharma announces US FDA approval for Alyglo (immune globulin intravenous, human-stwk) 10% liquid for adults with primary humoral immunodeficiency
18 December 2023 - - GC Biopharma today announces that the US FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% ...
Posted by Michael Wonder on 18 Dec 2023
EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for paediatric ADHD patients aged 13-17
18 December 2023 - Akili’s clinically proven digital medicine now authorised for children 8-17, opening option to more patients as ...
Posted by Michael Wonder on 18 Dec 2023
Zai Lab announces the first listing of Vyvgart (efgartigimod alfa) and other updates in China’s National Reimbursement Drug List
12 December 2023 - Zai Lab today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 18 Dec 2023
Leo Pharma announces US FDA approval of Adbry (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis in paediatric patients aged 12-17 years
15 December 2023 - In the ECZTRA 6 trial, significantly more paediatric patients met the primary and key secondary endpoints of ...
Posted by Michael Wonder on 18 Dec 2023
EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa
15 December 2023 - EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping ...
Posted by Michael Wonder on 18 Dec 2023
CHMP issues positive opinion for Biogen’s Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...
Posted by Michael Wonder on 18 Dec 2023
EMA recommends arpraziquantel for treatment of schistosomiasis in pre-school aged children
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
Posted by Michael Wonder on 17 Dec 2023
FDA approves Arcutis’ Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older
15 December 2023 - Commercial product expected to be available by end of January. ...
Posted by Michael Wonder on 17 Dec 2023
Recommendations made by the PBAC (November 2023)
18 December 2023 - Recommendations made by the PBAC in November 2023 relating to the listing of medicines on the ...
Posted by Michael Wonder on 16 Dec 2023
Has the Centers for Medicare Medicaid Services implicitly adopted a value framework for Medicare drug price negotiations?
15 December 2023 - The US Inflation Reduction Act of 2022 created several major policy changes to the pricing of prescription ...
Posted by Michael Wonder on 16 Dec 2023
Report on the collection of under co-payment data 2022-23
15 December 2023 - The report on the collection of under co-payment data 2022-23 is now available. ...
Posted by Michael Wonder on 16 Dec 2023
Biden Administration to impose inflation penalties on dozens of drugs
15 December 2023 - The Biden Administration said on Thursday it had identified 48 drugs in the Medicare program whose ...
Posted by Michael Wonder on 16 Dec 2023
Vertex receives CHMP positive opinion for the first CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
15 December 2023 - If approved by the European Commission, patients 12 years of age and older with severe sickle cell ...