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 08 Dec 2021
Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics announce the initiation of rolling submission of a new drug application for CUTX-101, copper histidinate, for treatment of Menkes disease
7 December 2021 - Cyprium Therapeutics with support from its licensing partner Sentynl Therapeutics today announced the initiation of a ...
Posted by Michael Wonder on 08 Dec 2021
Saol Therapeutics announces FDA approval of Lyvispah (baclofen) oral granules
7 December 2021 - Saol Therapeutics today announced that the U.S. FDA has approved Saol's Lyvispah (baclofen) oral granules. ...
Posted by Michael Wonder on 07 Dec 2021
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
7 December 2021 - ‘Mix-and-match’ approach can be used for both initial courses and boosters. ...
Posted by Michael Wonder on 07 Dec 2021
Daré announces FDA approval of Xaciato (clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis
7 December 2021 - Prescribing information supports positioning of Xaciato as a first line option for the treatment of bacterial ...
Posted by Michael Wonder on 07 Dec 2021
Remarks by President Biden on prescription drug costs
6 December 2021 - Today, I’d like to talk about how we’re going to help millions of Americans protect and ...
Posted by Michael Wonder on 07 Dec 2021
FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options
7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...
Posted by Michael Wonder on 07 Dec 2021
Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...
Posted by Michael Wonder on 07 Dec 2021
Zai Lab announces inclusion of Zejula (niraparib) in China’s National Reimbursement Drug List for first-line ovarian cancer
3 December 2021 - Zai Lab today announced that the National Reimbursement Drug List released by China’s National Healthcare Security Administration ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 07 Dec 2021
China clears insurance coverage for Kainos Medicine’s HIV drug
6 December 2021 - A home-grown HIV treatment developed by Kainos Medicine and out-licensed to China’s Jiangsu Aidea Pharmaceuticals has ...
Posted by Michael Wonder on 07 Dec 2021
Spectrum Pharmaceuticals submits new drug application for poziotinib
6 December 2021 - Fast track application is based on positive data in NSCLC HER2 exon 20 insertion mutations in previously ...
Posted by Michael Wonder on 07 Dec 2021
EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD
6 December 2021 - Olipudase alfa has been granted PRIority MEdicines (PRIME) designation in Europe, breakthrough therapy designation in the United ...
Posted by Michael Wonder on 07 Dec 2021
ICMRA high-level meeting on global health emergencies and regulatory approaches
6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...
Posted by Michael Wonder on 07 Dec 2021
Biosimilar follitropin alfa on the PBS - information for health care professionals and patients
7 December 2021 - A biosimilar brand of follitropin alfa (Ovaleap) was listed on the PBS on 1 December 2021. ...
Posted by Michael Wonder on 07 Dec 2021
Product approval and public health at the US Food and Drug Administration
6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in ...