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 13 Jan 2022
Mitsubishi Tanabe Pharma America announces FDA acceptance of new drug application for oral edaravone formulation for the treatment of ALS
12 January 2022 - Mitsubishi Tanabe Pharma America today announced the U.S. FDA has accepted the new drug application for an ...
Posted by Michael Wonder on 13 Jan 2022
Quebec to impose health tax on unvaccinated Canadians
12 January 2022 - The Canadian province of Quebec will charge a health tax to residents who are not vaccinated ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 13 Jan 2022
CMS proposes Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease
11 January 2022 - Today, the Centers for Medicare & Medicaid Services released a proposed National Coverage Determination decision memorandum. ...
Posted by Michael Wonder on 12 Jan 2022
Biden-Harris Administration requires insurance companies and group health plans to cover the cost of at home COVID-19 tests, increasing access to free tests
10 January 2022 - As part of its on-going efforts across many channels to expand Americans’ access to free testing, the ...
Posted by Michael Wonder on 12 Jan 2022
Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia
10 January 2022 - The approval of Quviviq – 25 & 50 mg – is based on a robust Phase 3 ...
Posted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...
Posted by Michael Wonder on 11 Jan 2022
NICE recommends Rinvoq for psoriatic arthritis patients
10 January 2022 - The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Lumykras (sotorasib) for patients with KRAS G12C mutated advanced non-small cell lung cancer
10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...
Posted by Michael Wonder on 11 Jan 2022
CARsgen announces CT041 CAR T-cell product candidate granted RMAT designation by the FDA
10 January 2022 - CARsgen Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CT041 for ...
Posted by Michael Wonder on 11 Jan 2022
SIGA Technologies receives approval from the European Medicines Agency for tecovirimat
10 January 2021 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...
Posted by Michael Wonder on 11 Jan 2022
4D Molecular Therapeutics announces FDA fast track designation granted to 4D-125 for the treatment of X-linked retinitis pigmentosa
10 January 2022 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation for 4D-125 for treatment ...
Posted by Michael Wonder on 11 Jan 2022
Veru announces FDA grant of fast track designation for enobosarm for the treatment of androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer
10 January 2022 - Phase 3 ARTEST registration study of enobosarm in patients with androgen receptor positive, oestrogen receptor positive, human ...