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 2020
Telix granted TGA priority review for prostate cancer imaging
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
Posted by Michael Wonder on 08 Dec 2020
Carlsmed aprevo granted unprecedented decision by FDA
8 December 2020 - -Carlsmed today announced it has been granted 510(k) clearance and breakthrough device designation by the FDA for ...
Posted by Michael Wonder on 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...
Posted by Michael Wonder on 08 Dec 2020
Pfizer's vaccine offers COVID-19 protection after first dose, FDA says
9 December 2020 - Pfizer has cleared the next hurdle in the race to get its COVID-19 vaccine approved for ...
Posted by Michael Wonder on 08 Dec 2020
Turf war: pharmacists will deliver COVID-19 vaccine despite GP concerns
9 December 2020 - Pharmacists will be able to administer COVID-19 vaccinations when the wider immunisation program begins in mid-2021, ...
Posted by Michael Wonder on 08 Dec 2020
Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
8 December 2020 - The EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for ...
Posted by Michael Wonder on 08 Dec 2020
Three reasons the drug industry should be worried about Biden’s HHS pick, Xavier Becerra
8 December 2020 - For a pharmaceutical industry that has spent two years sparring with health secretary Alex Azar, a ...
Posted by Michael Wonder on 08 Dec 2020
NICE backs AstraZeneca's Calquence for chronic lymphocytic leukaemia
8 December 2020 - NICE has published preliminary guidelines backing use of AstraZeneca's Calquence (acalabrutinib) as an NHS funded treatment ...
Posted by Michael Wonder on 08 Dec 2020
TLV wants to go further with combination treatments in the field of cancer
7 December 2020 - Part of the solution for more patients to have access to combination treatments may be to create ...
Posted by Michael Wonder on 08 Dec 2020
CDER focuses on novel drug development tools to help speed creation of new therapies
7 December 2020 - There are many novel drug development tools that incorporate the latest advances in science and technology but ...
Posted by Michael Wonder on 08 Dec 2020
Less than a third of Americans will definitely get the COVID vaccine: poll
4 December 2020 - Less than a third of Americans say they will definitely get the COVID-19 vaccine when it ...
Posted by Michael Wonder on 08 Dec 2020
Britain begins vaccine rollout, first person vaccinated
8 December 2020 - A 90-year-old British grandmother has become the first person in the world to receive the Pfizer ...
Posted by Michael Wonder on 08 Dec 2020
Statement on litigation challenging legality of the Administration’s most favoured nation rule
4 December 2020 - Today, the Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon ...
Posted by Michael Wonder on 07 Dec 2020
New report on TLV's medical technology assignment
3 December 2020 - In a new report, the Swedish Dental and Pharmaceutical Benefits Agency, TLV, reports on the work that ...
Posted by Michael Wonder on 07 Dec 2020
EMA publishes agenda for 7-10 December CHMP meeting
7 December 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...