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 13 Jun 2022
Medicines Australia moves quickly to put HTA system reform high on new Government’s agenda
10 June 2022 - Medicines Australia has moved quickly to ensure that major reform of Australia’s health technology assessment system ...
Posted by Michael Wonder on 13 Jun 2022
SMC - June 2022 decisions
13 June 2022 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 13 Jun 2022
FDA accepts application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy for stage IB (≥4 cm)-IIIA non-small-cell lung cancer following complete surgical resection
13 June 2022 - Acceptance based on results from the Phase 3 KEYNOTE-091 trial, the seventh positive pivotal trial evaluating ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 13 Jun 2022
BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...
Posted by Michael Wonder on 13 Jun 2022
Mallinckrodt announces resubmission of terlipressin to the FDA for the treatment of hepatorenal syndrome
13 June 2022 - Mallinckrodt today announced the resubmission of the Company's new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Jun 2022
FDA approves first systemic treatment for alopecia areata
13 June 2022 - Today, the U.S. FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, ...
Posted by Michael Wonder on 12 Jun 2022
Zai Lab announces breakthrough therapy designations granted for repotrectinib in China
10 June 2022 - Breakthrough therapy designations granted for ROS1 positive non-small-cell lung cancer patients pretreated with one prior line of ...
Posted by Michael Wonder on 12 Jun 2022
Harvard professors continue to push misconceptions to justify drug price controls
10 June 2022 - The biopharmaceutical industry performed wonderfully during the COVID-19 pandemic. ...
Posted by Michael Wonder on 12 Jun 2022
NRx Pharmaceuticals provides update on breakthrough therapy designation request for Zyesami (aviptadil)
10 June 2022 - NRx Pharmaceuticals today announced that the U.S. FDA denied the breakthrough therapy designation request for Zyesami (aviptadil) ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 10 Jun 2022
Everest Medicines announces approval of Trodelvy in China for second-line metastatic triple negative breast cancer
10 June 2022 - Everest plans to launch commercial sales of Trodelvy in China in Q4, 2022. ...
Posted by Michael Wonder on 10 Jun 2022
Hundreds of thousands set to benefit as NICE final draft guidance recommends new treatment to prevent heart attacks and strokes in people with raised blood fats
10 June 2022 - NICE has today published final draft guidance which recommends icosapent ethyl for reducing the risk of cardiovascular ...
Posted by Michael Wonder on 09 Jun 2022
U.S. Senators ask regulators to clear drug patent 'thickets'
9 June 2022 - Letter asks U.S. Patent and Trademark Office to crack down on "highly similar" patents for single ...
Posted by Michael Wonder on 09 Jun 2022
Roxadustat for treating anaemia in people with chronic kidney disease
9 June 2022 - After considering the feedback from consultation, the Appraisal Committee has prepared a Final Appraisal Document on the ...