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RSS FeedPosted by Michael Wonder on 04 Mar 2025
Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
3 March 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 03 Mar 2025
Latigo Biotherapeutics granted FDA fast track designation for LTG-001, potential best in class Nav1.8 inhibitor for the non-opioid treatment of acute pain
3 March 2025 - LTG-001 demonstrated favourable safety and tolerability profile with predictable pharmacokinetics in Phase 1 trial. ...
Posted by Michael Wonder on 03 Mar 2025
TGA decides not to register lecanemab in Australia
3 March 2025 - BioArctic's partner Eisai announced today that the TGA has declined the approval of lecanemab as a treatment ...
Posted by Michael Wonder on 03 Mar 2025
FDA approves Genentech’s TNKase in acute ischaemic stroke in adults
3 March 2025 - TNKase (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years. ...
Posted by Michael Wonder on 03 Mar 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable non-small cell lung cancer
3 March 2025 - Recommendation based on AEGEAN Phase 3 trial results which showed Imfinzi reduced the risk of recurrence, ...
Posted by Michael Wonder on 03 Mar 2025
Canada’s Drug Agency publishes new guidance for rare disease registries in Canada
28 February 2025 - On Rare Disease Day — a global event dedicated to raising awareness for the millions of ...
Posted by Michael Wonder on 03 Mar 2025
Supporting the development of drugs for rare diseases - the importance of regulatory transparency
1 March 2025 - Transparency regarding the information submitted to the FDA and the agency’s decision making could have far-reaching ...
Posted by Michael Wonder on 03 Mar 2025
Amyloid cardiomyopathy drug Vyndamax to get health insurance from March
28 February 2025 - Vyndamax (tafamidis), a transthyretin amyloid cardiomyopathy medicine that has experienced difficulties getting on the health insurance ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 03 Mar 2025
Cushing’s disease: drug added to PBS
2 March 2025 - Australians suffering from the debilitating condition Cushing’s disease have scored a huge win after a vital ...
Posted by Michael Wonder on 03 Mar 2025
PHARMAC CE resigns
28 February 2025 - The Board of PHARMAC wishes to announce that its Chief Executive for the last 7 years, ...
Posted by Michael Wonder on 03 Mar 2025
New Zealand Pharmaceutical Schedule - 1 March 2025
1 March 2025 - The March 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Teva and Medincell announce FDA acceptance of supplemental new drug application for Uzedy (risperidone) extended release injectable suspension as a treatment for patients with bipolar I disorder
25 February 2025 - Uzedy is currently approved in the US as a subcutaneous long-acting injectable for use every one or ...