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 03 Jun 2021
Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera
3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review. ...
Posted by Michael Wonder on 03 Jun 2021
Most Americans support Medicare negotiation despite claims it would hurt innovation
3 June 2021 - A new West Health/Gallup survey finds nearly all Democrats (97%) and the majority of Republicans (61%) support ...
Posted by Michael Wonder on 03 Jun 2021
'We're not just all about the money' — PHARMAC defends why it still won't fund drug for rare children's disorder
3 June 2021 - Under-fire PHARMAC is defending the way it funds New Zealand's drugs, with the agency's director of operations, ...
Posted by Michael Wonder on 03 Jun 2021
FDA grants priority review for new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
3 June 2021 - PDUFA date of 30 November 2021 set for Oleogel-S10. ...
Posted by Michael Wonder on 03 Jun 2021
COVID-19 vaccine weekly safety report (3 June 2021)
3 June 2021 - Eight additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 03 Jun 2021
Quebec extends public reimbursement of Dupixent (dupilumab) for the treatment of moderate to severe atopic dermatitis to include adolescents
1 June 2021 - Public reimbursement under the Régie de l'assurance maladie du Québec will now apply for Canadians aged ...
Posted by Michael Wonder on 03 Jun 2021
Health Canada accepts new drug submission for Reduvo as a treatment for patients with chemotherapy-induced nausea and vomiting
2 June 2021 - Tetra Bio-Pharma announced today that Health Canada has accepted its new drug submission for Reduvo and has ...
Posted by Michael Wonder on 02 Jun 2021
FDA approves pricey pill to treat vaginal yeast infections
2 June 2021 - Regulators OK’d a new anti-fungal treatment, but critics say it is unneeded and costs too much. ...
Posted by Michael Wonder on 02 Jun 2021
FDA authorises marketing of diagnostic aid for autism spectrum disorder
2 June 2021 - Today, the U.S. FDA authorised marketing of a device to help diagnose autism spectrum disorder. ...
Posted by Michael Wonder on 02 Jun 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...
Posted by Michael Wonder on 02 Jun 2021
Experts expect to see “second wave” of biosimilars approvals
2 June 2021 - Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges ...
Posted by Michael Wonder on 02 Jun 2021
Health Canada approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as the first and only immunotherapy treatment for previously untreated unresectable malignant pleural mesothelioma
2 June 2021 - First new systemic therapy in more than 15 years for cancer related to asbestos exposure. ...
Posted by Michael Wonder on 02 Jun 2021
NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group
2 June 2021 - NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in ...
Posted by Michael Wonder on 02 Jun 2021
Bausch Health and Clearside Biomedical announce U.S. FDA filing acceptance for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
2 June 2021 - PDUFA action date Is 30 October 2021. ...
Posted by Michael Wonder on 02 Jun 2021
Boehringer Ingelheim and Zealand Pharma receive FDA fast track designation for investigational treatment for NASH
2 June 2021 - FDA’s fast track designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options ...