Blog
RSS FeedPosted by Michael Wonder on 18 Apr 2025
Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients
17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...
Posted by Michael Wonder on 16 Apr 2025
Scilex announces approval of a new drug submission from the Health Canada for Elyxyb’s acute treatment of migraine with or without aura in Canada
15 April 2025 - Elyxyb is a first-line treatment and the only FDA approved, ready to use oral solution for the ...
Posted by Michael Wonder on 15 Apr 2025
Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults
14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...
Posted by Michael Wonder on 11 Apr 2025
Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer
10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 28 Mar 2025
Takeda’s HyQvia receives expanded market authorisation as maintenance therapy for chronic inflammatory demyelinating polyneuropathy
27 March 2025 - HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous ...
Posted by Michael Wonder on 21 Mar 2025
Hikma announces Health Canada approval of Kloxxado (naloxone hydrochloride) nasal spray 8 mg
20 March 2025 - Emergent BioSolutions will lead commercial launch efforts to increase access to intranasal naloxone and combat opioid overdose ...
Posted by Michael Wonder on 20 Mar 2025
Health Canada approves Keytruda for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, in combination with carboplatin and paclitaxel and then continued as monotherapy
19 March 2025 - Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 trial. ...
Posted by Michael Wonder on 18 Mar 2025
Zorvye cream 0.15% approved by Health Canada for the treatment of mild to moderate atopic dermatitis in adults and children as young as six years of age
17 March 2025 - Once daily, steroid free topical treatment designed to rapidly reduce itch and proactively support long term disease ...
Posted by Michael Wonder on 18 Mar 2025
Skyclarys (omaveloxolone) approval by Health Canada ushers in a new era for Friedreich's ataxia treatment in Canada
17 March 2025 - As the only approved treatment to address disease progression, Skyclarys addresses a long standing gap in the ...
Posted by Michael Wonder on 11 Mar 2025
Health Canada authorises Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
10 March 2025 - Phase 3 MARIPOSA study showed Lazcluze plus Rybrevant significantly improved progression-free survival, reducing the risk of ...
Posted by Michael Wonder on 08 Mar 2025
Acarizax approved in Canada for treatment of young children
7 March 2025 - ALK today announced that Health Canada has approved ALK’s Acarizax tablet for use in children, aged ...
Posted by Michael Wonder on 07 Mar 2025
Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)
6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...
Posted by Michael Wonder on 04 Mar 2025
Qalsody (tofersen injection) receives conditional marketing authorisation from Health Canada as the first ALS treatment targeting a genetic cause
3 March 2025 - Biogen's second rare disease therapy to be approved in Canada reflects a continued commitment to advancing ...
Posted by Michael Wonder on 27 Feb 2025
Kashiv BioSciences obtains marketing authorisation for pegfilgrastim injection from Health Canada
25 February 2025 - Kashiv BioSciences today announced that Health Canada has granted marketing authorisation for its pegfilgrastim injection, enabling its ...