Health Canada

Showing 10 posts of 10 posts found.

DiaMedica gets regulatory clearance from Health Canada for phase 2 preeclampsia study

March 11, 2026
Research and Development DiaMedica, Health Canada, preeclampsia

DiaMedica Therapeutics has received a No Objection Letter (NOL) from Health Canada, giving the company regulatory clearance to start its …

Alvotech and JAMP Pharma’s Jamteki gains marketing authorisation from Health Canada

November 15, 2023
Medical Communications Alvotech, Health Canada, JAMP Pharma, Pharmacy, biosimilar

Alvotech and JAMP Pharma have announced that Health Canada has granted JAMP Pharma marketing authorisation for AVT04, a biosimilar to …

Health Canada approves Ipsen and Medision Pharma’s Bylvay for pruritus treatment

November 14, 2023
Medical Communications Health Canada, Medision Pharma, Rare Diseases, ipsen, pruritis

Ipsen and Medision Pharma have announced that Health Canada has approved Bylvay (odevixibat) for the treatment of pruritis in patients …

Health Canada announce first full approval for Moderna COVID-19 vaccine

September 17, 2021
Medical Communications AstraZeneca, BioNTech, Health Canada, Moderna, Pfizer, mrna

Canada has become the first country in the world to grant full approval to the Moderna vaccine, alongside confirmation for …

fda-headquarters-gty-jc-181127_hpmain_12x5_608

FDA investigating if carcinogen NDMA is in diabetes drug

December 6, 2019
Medical Communications FDA, Health Canada, MDMA, NDMA, carcinogen, diabetes

The FDA is looking into if the diabetes drug metformin has unsafe levels of a cancer-causing chemical. This comes after …

FDA approves AstraZeneca’s Calquence in chronic lymphoma

November 25, 2019
Sales and Marketing Astrazenaca, Calquence, FDA, Health Canada, leukaemia, oncology

The FDA has approved AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic …

US, Canada and Australia simultaneously fast-track Keytruda/Lenvima combo for endometrial cancer

September 18, 2019
Research and Development, Sales and Marketing Australian Therapeutic Goods Administration, Cancer, FDA, Health Canada, Lenvima, keytruda, pharma

The FDA has acted under a new initiative in collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, …

Raptor’s Procysbi gets Priority Review from Health Canada

March 22, 2016
Manufacturing and Production, Research and Development Canada, Health Canada, Procysbi, Raptor Pharmaceutical, genetic condition

Raptor Pharmaceutical (Nasdaq: RPTP) said Canadian regulators have accepted a priority review for its drug to treat a rare genetic …

FDA image

Regulators ‘more efficient at approving drugs’

January 19, 2015
Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters

Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …

Pharma manufacturing news in brief

November 20, 2012
Manufacturing and Production Alfa Laval, Boehringer, Fujifilm, Health Canada, Novartis

Our latest round-up of manufacturing news includes a facility contract for Alfa Laval, plus updates from Fujifilm, Novartis, Boehringer Ingelheim …

The Gateway to Local Adoption Series

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