Health Canada

1190 articles with Health Canada

• Notice of Compliance issued regarding Rezurock(TM) (belumosudil tablets)

  3/21/2023

  sanofi-aventis Canada Inc. is pleased to announce that Health Canada has issued a Notice of Compliance for Rezurock™, for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.

• Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials

  3/18/2023

  Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots of the cystic fibrosis drug Cayston on March 1, 2023, due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.

• Numinus Receives Clinical Trial Application Approval from Health Canada for Experiential Psychedelic-Assisted Therapy Training using Psilocybe Cubensis Tea

  2/1/2023

  Numinus Wellness Inc. today announced that it has received approval from Health Canada for its experiential training study that will test the safety and clinical efficacy of whole Psilocybe cubensis tea for therapeutic use, and enable practitioners to further their understanding of psychedelic-assisted therapy through experiential training. 

• Edesa Biotech Receives Regulatory Approval for Phase 2 Vitiligo Study

  2/1/2023

  Edesa Biotech, Inc. today announced that it has received approval from Health Canada for a Phase 2 clinical study of the company's EB06 monoclonal antibody candidate as a treatment for vitiligo.

• Diamond Therapeutics Announces Health Canada Approval of Phase 2 Clinical Trial with Low-Dose Psilocybin

  1/24/2023

  Diamond Therapeutics Inc. is pleased to announce it has received Health Canada approval to begin a Phase 2 clinical trial evaluating the safety, tolerability and efficacy of repeat low-doses of psilocybin for the treatment of generalized anxiety disorder (GAD).

• Apex Labs Granted Approval for 294 Patient Take Home Psilocybin Clinical Trial

  1/19/2023

  Apex Labs Ltd. (APEX or the Company), a pharmaceutical company optimizing the standard of mental health care with psilocybin, is pleased to announce its approval by Health Canada to begin APEX-002-A01-03, the world's largest take home psilocybin clinical trial approved to date.

• Ultomiris approved in Canada for adults with generalized myasthenia gravis (gMG)

  1/17/2023

  Ultomiris (ravulizumab) has been approved in Canada for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.1 [PM, p.4A]

• GERMSTOP(SQ) IS FIRST EVER DISINFECTANT TO KILL HUMAN CORONAVIRUS 229E ON SURFACES FOR UP TO 24 HOURS

  1/17/2023

  GermStopSQ has been issued a Notice of Compliance by Health Canada and granted a Drug Identification Number, making Good Theorem the first to launch a residual* disinfectant that keeps killing 99.999% of bacteria and 99.9% of Human Coronavirus 229E for 24 hours, making it the first of its kind on the market.

• Enhertu Approved by Health Canada as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer

  1/12/2023

  Health Canada approved Enhertu ™ (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

• Novocure’s Optune® Approved in Canada for the Treatment of Newly Diagnosed and Recurrent Glioblastoma

  11/29/2022

  Novocure (NASDAQ: NVCR) today announced that Health Canada has approved Optune® for the treatment of newly diagnosed and recurrent glioblastoma (GBM).

• Health Canada Authorizes POLIVY® (polatuzumab vedotin for injection) for the First-Line Treatment of Adults With Large B-Cell Lymphoma

  11/24/2022

  Hoffmann-La Roche Limited is pleased to announce that on November 14, 2022, Health Canada has authorized POLIVY® in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high grade B-cell lymphoma, Epstein-Barr virus-positive DLBCL NOS, and T-cell/histiocyte rich LBCL.

• Advisory - Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer

  11/1/2022

  The Canadian labelling for all Janus Kinase inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer.

• Cerus Corporation Announces Health Canada Approval for INTERCEPT Blood System for Platelets with Seven-Day Storage

  11/1/2022

  Cerus Corporation (Nasdaq:CERS) today announced it has received approval from Health Canada to extend the storage of platelets treated with the INTERCEPT Blood System from five days to seven days from the time of collection, joining other territories where INTERCEPT platelets are approved for seven-day storage.

• Sonendo® Announces Health Canada Regulatory Approval for Next Generation GentleWave® G4 System

  11/1/2022

  Sonendo , Inc. (NYSE: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that it has received Health Canada regulatory approval for commercial sales of its recently announced GentleWave G4 System.

• XORTX Receives Further No Objection Letter from Health Canada

  10/26/2022

  XORTX Therapeutics Inc. is pleased to announce receipt of a further no objection letter from Health Canada regarding the Company’s ongoing XRX-OXY101 clinical bridging pharmacokinetics study.

• Health Canada Approves KEYTRUDA (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC)

  10/12/2022

  Merck announced that Health Canada has granted approval for KEYTRUDA ®  (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC).

• Update on Supply of Children's Acetaminophen and Ibuprofen Products

  10/7/2022

  We share the concerns of many parents and caregivers about their inability to find pediatric/infant and children's acetaminophen and ibuprofen products, and we understand the worries associated with this.

• Health Canada approves additional indication for NUBEQA® (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

  10/5/2022

  Bayer Inc. announced that Health Canada, following a priority review, has approved NUBEQA® for the treatment of patients with metastatic castration-sensitive prostate cancer in combination with docetaxel1.

• Government of Canada to remove COVID-19 border and travel measures effective October 1

  9/26/2022

  Since the beginning of the pandemic, the Government of Canada has taken a layered approach to border management to protect the health and safety of Canadians.

• Government of Canada announces appointments to the Canadian Institutes of Health Research Governing Council

  9/21/2022

  The Honourable Jean-Yves Duclos, Minister of Health, announced three appointments and one reappointment to the Canadian Institutes of Health Research Governing Council.