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 Sep 2022
Vedolizumab for the treatment of patients with chronic refractory pouchitis
21 September 2022 - NICE is unable to make a recommendation about the use in the NHS of vedolizumab for the ...
Posted by Michael Wonder on 23 Sep 2022
Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine
22 September 2022 - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further ...
Posted by Michael Wonder on 23 Sep 2022
Bracco announces FDA approval of gadopiclenol injection, a new macrocyclic high-relaxivity gadolinium-based contrast agent which will be commercialised as Vueway
21 September 2022 - Vueway injection is highly stable and shows the highest relaxivity among gadolinium-based contrast agents available for ...
Posted by Michael Wonder on 23 Sep 2022
Kinnate Biopharma receives fast track designation from the US Food and Drug Administration for KIN-2787, an investigational pan-RAF inhibitor
21 September 2022 - Kinnate Biopharma today announced that the US FDA has granted Fast Track designation for Kinnate’s investigational ...
Posted by Michael Wonder on 23 Sep 2022
Lynparza approved in China as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
22 September 2022 - One in two women with advanced ovarian cancer has an HRD positive tumour. ...
Posted by Michael Wonder on 22 Sep 2022
13 million Novavax doses due to expire as Australians stick to mRNA boosters
21 September 2022 - Novavax COVID vaccines procured by the federal government in the hopes of convincing hesitant Australians to ...
Posted by Michael Wonder on 22 Sep 2022
PHARMAC plans switch back to broader pneumococcal vaccine, following surge in deadly disease cases
21 September 2022 - PHARMAC plans to give all babies access to a broader pneumococcal vaccine from December, after a ...
Posted by Michael Wonder on 22 Sep 2022
CADTH recommendation to not reimburse new treatment a failure for people living with schizophrenia
21 September 2022 - The Schizophrenia Society of Canada is joined by the schizophrenia community across Canada in its disappointment with ...
Posted by Michael Wonder on 22 Sep 2022
BridgeBio Pharma and Sentynl Therapeutics receive marketing authorisation in the EU for Nulibry (fosdenopterin) for the treatment of MOCD type A
20 September 2022 - Nulibry was BridgeBio’s first FDA approved therapeutic; Sentynl acquired global rights to Nulibry in March 2022. ...
Posted by Michael Wonder on 21 Sep 2022
The Inflation Reduction Act aims to lower drug costs — but here’s how big pharma could get around it
21 September 2022 - The tactics may ultimately threaten the law’s ability to lower drug costs for many in the US. ...
Posted by Michael Wonder on 21 Sep 2022
FDA approves selpercatinib for locally advanced or metastatic RET fusion positive non-small-cell lung cancer
21 September 2022 - Today, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly) for adult ...
Posted by Michael Wonder on 21 Sep 2022
The on- and off-ramps of oncology accelerated approval
21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...
Posted by Michael Wonder on 21 Sep 2022
FDA approves selpercatinib for locally advanced or metastatic RET fusion positive solid tumours
21 September 2022 - Today, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for adult ...
Posted by Michael Wonder on 21 Sep 2022
argenx submits biologics license application to US Food and Drug Administration for subcutaneous efgartigimod for treatment of generalised myasthenia gravis
21 September 2022 - Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating non-inferiority of subcutaneous efgartigimod ...
Posted by Michael Wonder on 21 Sep 2022
Guerbet announces US FDA approval of Elucirem (gadopiclenol)
21 September 2022 - FDA approval of Elucirem was granted after priority review, a designation assigned to applications for drugs ...