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 Dec 2020
Fortress Biotech announces breakthrough therapy designation for CUTX-101, copper histidinate, for the treatment of Menkes disease
15 December 2020 - Rolling submission of new drug application to the FDA for CUTX-101 on track to begin in the ...
Posted by Michael Wonder on 16 Dec 2020
Health Canada approves Venclexta (venetoclax) in combination with azacitidine or low dose cytarabine for untreated acute myeloid leukaemia
15 December 2020 - Health Canada's approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...
Posted by Michael Wonder on 16 Dec 2020
Spark Biomedical receives FDA breakthrough device designation for infant transcutaneous auricular neurostimulation device, the Roo system
15 December 2020 - Breakthrough designation helps advance the therapy targeting a significant unmet need in the treatment of neonatal opioid ...
Posted by Michael Wonder on 16 Dec 2020
Exero Medical's smart sensor granted FDA breakthrough designation
15 December 2020 - Designation to expedite regulatory clearance process for Exero Medical's system, providing data on internal tissue healing in ...
Posted by Michael Wonder on 16 Dec 2020
US FDA approves world’s first rapid Covid test from Brisbane’s Ellume
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...
Posted by Michael Wonder on 15 Dec 2020
Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
Posted by Michael Wonder on 15 Dec 2020
New criteria changes who’ll get COVID-19 vaccine first
16 December 2020 - Australia’s population is expected to be divided into 12 age brackets for the much-anticipated rollout of ...
Posted by Michael Wonder on 15 Dec 2020
Vaccination strategy against SARS-Cov-2
15 December 2020 - Intermediate recommendations on the methods of implementing vaccination. ...
Posted by Michael Wonder on 15 Dec 2020
Big Pharma’s new CEOs must step up to erase inequities in drug access
16 December 2020 - I have been asked many times: Does the vision of the CEO have the power to ...
Posted by Michael Wonder on 15 Dec 2020
FDA committee to meet again Thursday for Moderna's COVID-19 vaccine
14 December 2020 - A Food and Drug Administration advisory committee will meet for the second time in a week to ...
Posted by Michael Wonder on 15 Dec 2020
Trump’s plan for $200 Medicare drug cards advances, though hurdles remain
15 December 2020 - An industry group that ensures standards are met for health-benefit cards gave its approval for the $200 ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. ...
Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data ...