Health Canada

The developer of the add-on treatment masitinib for amyotrophic lateral sclerosis (ALS) has been given the go-ahead to ask Health Canada to reconsider its decision from earlier this year against the approval of the oral therapy. The Canadian regulatory agency granted reconsideration eligibility to AB Science for…

Health Canada is now reviewing Qalsody (tofersen) as a potential treatment for people with amyotrophic lateral sclerosis (ALS) who carry mutations in the SOD1 gene, according to the therapy’s developer Biogen. The Canadian regulatory authority agreed to review Biogen’s application for the therapy’s approval, with its decision expected in early 2025, according to…

Health Canada has issued a notice of noncompliance-withdrawal saying it won’t approve the oral therapy masitinib as an add-on treatment for amyotrophic lateral sclerosis (ALS). Its developer, AB Science, can submit a request for reconsideration within the next month, which it plans to do, it announced in…

Health Canada has resumed its review of AB Science’s application seeking approval of masitinib, an oral add-on therapy for amyotrophic lateral sclerosis (ALS), after the agency halted its review late last year. In 2022, the agency agreed to review the application under the notice of compliance with…

AB Science has submitted its response to the European Medicines Agency (EMA), part of an ongoing review process aiming for the conditional approval of masitinib as an add-on oral therapy for amyotrophic lateral sclerosis (ALS). The Committee for Medicinal Products for Human Use (CHMP), an arm…

Health Canada asked more information regarding masitinib as a potential add-on therapy for amyotrophic lateral sclerosis (ALS) before continuing to review a request for its approval. AB Science, masitinib’s developer, now has 90 consecutive days to reply to the notice of deficiency issued by Health Canada, given…

Albrioza, formerly called AMX0035, has been given conditional approval by Health Canada for the treatment of amyotrophic lateral sclerosis (ALS). The decision marks a first approval for Albrioza by a regulatory authority in any country and the first new ALS therapy to enter the Canadian market since 2018.

Health Canada has started to review AB Science’s application requesting that masitinib be approved as an add-on therapy for amyotrophic lateral sclerosis (ALS). The application will be reviewed under the notice of compliance with conditions (NOC/c) policy, agreed upon with the agency in February. This policy allows early…

Health Canada has authorized a new drug submission for masitinib — AB Science’s add-on therapy for amyotrophic lateral sclerosis (ALS) — under the notice of compliance with conditions policy (NOC/c), designed to get new medications to patients more quickly. If granted, this would allow conditional marketing of…

Health Canada has agreed to review Amylyx Pharmaceuticals‘ application seeking approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). “We are pleased that our submission has been accepted for review by Health Canada, and we are committed to serving those affected by ALS in the…