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 Aug 2021
Abbott's Amplatzer Amulet device approved by FDA to treat people with atrial fibrillation at risk of stroke
16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...
Posted by Michael Wonder on 16 Aug 2021
Merck Canada initiates rolling submission to Health Canada for molnupiravir, an investigational oral therapeutic agent for the treatment of COVID-19
13 August 2021 - Merck today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice ...
Posted by Michael Wonder on 16 Aug 2021
PHARMAC must explain funding decisions
16 August 2021 - “A report this morning that all PHARMAC staff, rather than clinical experts or those with patient ...
Posted by Michael Wonder on 16 Aug 2021
Spinal muscular atrophy: second and third active ingredients undergo benefit assessment
16 August 2021 - With risdiplam there is a hint of an added benefit for spinal muscular atrophy type 1, ...
Posted by Michael Wonder on 16 Aug 2021
Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy
16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...
Posted by Michael Wonder on 16 Aug 2021
Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer
16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...
Posted by Michael Wonder on 16 Aug 2021
Lanadelumab in hereditary angioedema: added benefit not proven
16 August 2021 - The active ingredient has exceeded the sales limit for the simplified orphan drug assessment. There are no ...
Posted by Michael Wonder on 16 Aug 2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...
Posted by Michael Wonder on 16 Aug 2021
Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
16 August 2021 - Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine ...
Posted by Michael Wonder on 16 Aug 2021
FDA approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps
16 August 2021 - U.S. approval of pump use for Lilly's novel insulin is latest development designed to help people ...
Posted by Michael Wonder on 16 Aug 2021
Government of Canada negotiates additional agreement with Moderna for vaccine supply beyond 2021
13 August 2021 - The Government of Canada is committed to protecting the health and safety of Canadians by securing ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 16 Aug 2021
InxMed's IN10018 receives U.S. FDA fast track designation for the treatment of platinum-resistant ovarian cancer
16 August 2021 - InxMed announced today the U.S. FDA has granted fast track designation to IN10018 for the treatment of ...
Posted by Michael Wonder on 16 Aug 2021
U.S. FDA approves Ticovac, Pfizer's tick borne encephalitis vaccine
13 August 2021 - Ticovac may help reduce the risk of tick-borne encephalitis for people traveling to endemic areas, potentially including ...
Posted by Michael Wonder on 15 Aug 2021
Australia secures one million Pfizer doses from Poland, with more than half destined for Sydney
15 August 2021 - Poland has come to Australia’s rescue with an extra one million Pfizer doses after the government went ...