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 18 Dec 2025
Alnylam announces Health Canada approval of Amvuttra (vutrisiran), the first and only RNAi therapeutic for the treatment of cardiomyopathy in adult patients with ATTR amyloidosis
16 December 2025 - Alnylam Canada is pleased to announce that Health Canada has issued a Notice of Compliance authorising Amvuttra ...
Posted by Michael Wonder on 18 Dec 2025
Chiesi Global Rare Diseases announces Health Canada approval of Elfabrio (pegunigalsidase alfa) for Fabry disease
16 December 2025 - Chiesi Global Rare Diseases today announced the Health Canada approval of Elfabrio (pegunigalsidase alfa) for the treatment ...
Posted by Michael Wonder on 17 Dec 2025
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
17 December 2025 - Today, the FDA approved rucaparib (Rubraca, pharmaand) for adults with a deleterious BRCA mutation (germline and/or ...
Posted by Michael Wonder on 17 Dec 2025
Wegovy (semaglutide injection) receives conditional marketing authorisation from Health Canada as the first and only treatment for adults with non-cirrhotic MASH, a serious liver disease
15 December 2025 - Novo Nordisk announced today that Health Canada has issued marketing authorisation with conditions (Notice of Compliance ...
Posted by Michael Wonder on 17 Dec 2025
Vanda announces submission of biologics license application to the FDA for imsidolimab for the treatment of generalised pustular psoriasis
15 December 2025 - Vanda Pharmaceuticals today announced the submission of a biologics license application to the US FDA) for ...
Posted by Michael Wonder on 17 Dec 2025
Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma
16 December 2025 - Approval based on SWIFT trials showing significantly lower rate of annualised asthma exacerbations in patients receiving depemokimab ...
Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in ...
Posted by Michael Wonder on 16 Dec 2025
ICER publishes final evidence report on treatments for obesity
16 December 2025 - Independent committee voted unanimously on the positive net health benefit of all three treatments; final report ...
Posted by Michael Wonder on 16 Dec 2025
Palvella Therapeutics granted FDA fast track designation for Qtorin 3.9% rapamycin anhydrous gel for the treatment of angiokeratomas
16 December 2025 - Angiokeratomas are characterised by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of ...
Posted by Michael Wonder on 16 Dec 2025
Adagene announces FDA fast track designation for muzastotug (ADG126)
16 December 2025 - Adagene today announced that the US FDA has designated muzastotug, in combination with Merck’s anti-PD-1 therapy, Keytruda ...
Posted by Michael Wonder on 16 Dec 2025
Updated information about PHARMAC’s priority lists as at 15 December 2025
15 December 2025 - PHARMAC’s Prioritisation Update provides the latest information about applications for medicines, vaccines, and related products that ...
Posted by Michael Wonder on 16 Dec 2025
Aldeyra Therapeutics announces PDUFA extension of the new drug application of reproxalap for the treatment of dry eye disease
15 December 2025 - Aldeyra Therapeutics today announced that the US FDA has extended the PDUFA target action date for the ...
Posted by Michael Wonder on 16 Dec 2025
Historic first in women's sexual health: FDA grants approval for Addyi (flibanserin) in post-menopausal women
15 December 2025 - Sprout Pharmaceuticals today announced a monumental milestone for women's health: the US FDA has approved Addyi ...
Posted by Michael Wonder on 16 Dec 2025
Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus
16 December 2025 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union for subcutaneous self-administration as a pre-filled ...
Posted by Michael Wonder on 16 Dec 2025
Leo Pharma submits adolescent label expansion application for Anzupgo to EMA
15 December 2025 - Leo Pharma today announced submission of a label expansion application to the EMA to expand the ...