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RSS FeedPosted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 22 Sep 2021
Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada
22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...
Posted by Michael Wonder on 18 Sep 2021
Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma
17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...
Posted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 15 Sep 2021
Health Canada approves Lumakras (sotorasib), the first and only targeted treatment for patients with KRAS G12C mutated locally advanced or metastatic non--small cell lung cancer
14 September 2021 - Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found ...
Posted by Michael Wonder on 08 Sep 2021
Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults
7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...
Posted by Michael Wonder on 02 Sep 2021
Natco Pharma (Canada) announces the launch of Nat-Lenalidomide capsules, the first generic alternative to Revlimid
1 September 2021 - Nat-Lenalidomide expands affordable treatment options for patients with multiple myeloma and patients with transfusion-dependent anaemia due to ...
Posted by Michael Wonder on 01 Sep 2021
Amylyx Pharmaceuticals announces Health Canada accepts for review the new drug submission for AMX0035 for the treatment of ALS
31 August 2021 - Amylyx Pharmaceuticals today announced that Health Canada has accepted for review the new drug submission for AMX0035 ...
Posted by Michael Wonder on 01 Sep 2021
Jazz Pharmaceuticals announces Health Canada approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
31 August 2021 - Jazz Pharmaceuticals today announced the Health Canada approval and availability of Sunosi (solriamfetol) for the treatment ...
Posted by Michael Wonder on 30 Aug 2021
Health Canada approves Myinfla (colchicine 0.5 mg extended release tablets), a new repurposed treatment for cardiovascular disease
27 August 2021 - A unique partnership between Pharmascience and the Montreal Heart Institute leads to the approval of Myinfla (colchicine ...
Posted by Michael Wonder on 29 Aug 2021
Moderna COVID-19 vaccine gets Health Canada approval for kids 12+
27 August 2021 - As the Delta variant rages through unvaccinated populations in Canada ahead of the back-to-school season, children ...
Posted by Michael Wonder on 27 Aug 2021
BioCryst announces acceptance of regulatory applications for Orladeyo (berotralstat) by Health Canada and Swissmedic
25 August 2021 - BioCryst Pharmaceuticals today announced that the new drug submission for Orladeyo (berotralstat) has been accepted for ...
Posted by Michael Wonder on 25 Aug 2021
Vertex Pharma gets approval for cystic fibrosis drug for infants in Canada
25 August 2021 - Vertex Pharmaceuticals was given approval to market its drug ivacaftor that treats children as young as ...
Posted by Michael Wonder on 25 Aug 2021
Health Canada grants marketing authorisation for Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
24 August 2021 - Minjuvi is a new therapeutic option for eligible patients with DLBCL in Canada to address an ...