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 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
Posted by Michael Wonder on 04 Dec 2021
European Medicines Agency validates Amicus Therapeutics marketing authorisation applications for AT-GAA for the treatment of Pompe disease
3 December 2021 - Amicus Therapeutics today announced that the EMA validated the marketing authorisation applications for AT-GAA, the Company’s ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 04 Dec 2021
FDA expands authorisation of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to younger paediatric patients, including newborns
3 December 2021 - Today, the U.S. FDA revised the emergency use authorisation of bamlanivimab and etesevimab (previously authorised for paediatric ...
Posted by Michael Wonder on 03 Dec 2021
AbbVie provides update on Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis in the U.S.
3 December 2021 - AbbVie today announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for ...
Posted by Michael Wonder on 03 Dec 2021
FDA approves pembrolizumab for adjuvant treatment of stage IIB or IIC melanoma
3 December 2021 - On 3 December 2021, the FDA approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult ...
Posted by Michael Wonder on 03 Dec 2021
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...
Posted by Michael Wonder on 03 Dec 2021
FDA approves rituximab plus chemotherapy for paediatric cancer indications
3 December 2021 - On 2 December 2021, the FDA approved rituximab (Rituxan, Genentech) in combination with chemotherapy for pediatric ...
Posted by Michael Wonder on 03 Dec 2021
Agenda for the December 2021 PBAC intracycle meeting
3 December 2021 - The agenda for the December 2021 PBAC intracycle meeting is now available. ...
Posted by Michael Wonder on 03 Dec 2021
TOT Biopharm announces NMPA granted marketing approval for Pusintin (TAB008, bevacizumab) in China
1 December 2021 - TOT Biopharm announced its self-developed Pusintin (TAB008, bevacizumab) has been officially granted approval by the National ...
Posted by Michael Wonder on 03 Dec 2021
ZetaMet receives breakthrough device designation from U.S. FDA for treatment of metastatic bone cancers
1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...
Posted by Michael Wonder on 03 Dec 2021
ATAGI update following weekly COVID-19 meeting (1 December 2021)
3 December 2021 - On 1 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 02 Dec 2021
MHRA grants conditional marketing authorisation for COVID-19 treatment Xevudy (sotrovimab)
2 December 2021 - A supply agreement reached with UK government will enable access to sotrovimab for UK patients. ...
Posted by Michael Wonder on 02 Dec 2021
Harmonisation of health technology assessment across the European Union: lessons for the United States
2 December 2021 - In the multi-payer US system, each public program, private insurer, and self-insured employer conducts its own ...
Posted by Michael Wonder on 02 Dec 2021
PHARMAC in review (2021) - part 2
3 December 2021 - As expected, the interim report fails to address the elephant in the room. ...