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 23 Mar 2026
Enhertu now available in Japan as first antibody drug conjugate for the second-line treatment of patients with HER2 positive metastatic gastric cancer
23 March 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated statistically significant and clinically meaningful ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu approved in Japan as first tumour agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumours
23 March 2026 - Based on four Phase 2 trials where Enhertu demonstrated clinically meaningful responses across a broad range ...
Posted by Michael Wonder on 22 Mar 2026
IntraBio announces submission of supplemental new drug application for levacetylleucine for ataxia-telangiectasia
20 March 2026 - IntraBio today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Mar 2026
Toward greater transparency at the FDA - now is the time to act
18 March 2026 - The US FDA has generally sought to uphold the highest standards of scientific rigour in its regulation ...
Posted by Michael Wonder on 20 Mar 2026
Political influence ‘a serious problem’ for FDA under Trump, former commissioner says
19 March 2026 - Political influence ‘a serious problem’ for FDA under Trump, former commissioner says. ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 20 Mar 2026
NHS spending watchdog to review evidence on Alzheimer’s treatments
20 March 2026 - England’s drugs costs watchdog is to look again at whether new treatments for Alzheimer’s disease should ...
Posted by Michael Wonder on 20 Mar 2026
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
19 March 2026 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...
Posted by Michael Wonder on 20 Mar 2026
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
20 March 2026 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine for ...
Posted by Michael Wonder on 20 Mar 2026
DUSC utilisation analysis public release documents (October 2025)
20 March 2026 - The utilisation analysis public release documents from the October 2025 DUSC meeting are now available. ...
Posted by Michael Wonder on 20 Mar 2026
Public summary documents (first time decisions not to recommend and deferrals) – November 2025 PBAC meeting
20 March 2026 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the November 2025 PBAC ...
Posted by Michael Wonder on 19 Mar 2026
FDA approves fourth product under National Priority Voucher Program, higher dose semaglutide
19 March 2026 - The US FDA today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy ...
Posted by Michael Wonder on 19 Mar 2026
Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
19 March 2026 - Approval based on the positive GLISTEN Phase 3 trial with regulatory reviews underway in the EU, ...
Posted by Michael Wonder on 19 Mar 2026
Remix Therapeutics granted FDA fast track designation for REM-422 for the treatment of recurrent, metastatic or unresectable adenoid cystic carcinoma
19 March 2026 - Remix Therapeutics today announced that the US FDA has granted fast track designation to first-in-class small molecule ...
Posted by Michael Wonder on 19 Mar 2026
Myriad Genetics receives FDA approval of the MyChoice CDx test as the companion diagnostic for Zejula (niraparib) for patients with ovarian cancer
17 March 2026 - Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved ...