LONDON and GAITHERSBURG, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, announces the approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg, by Health Canada for the treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult patients. KLOXXADO® delivers 8 mg of naloxone...Read more
Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 Trial KIRKLAND, QC, March 19, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent...Read more
Once-daily, steroid-free topical treatment designed to rapidly reduce itch and proactively support long term disease control Rapid and significant improvements in disease clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) Success at week 4, with significant improvements seen as early as week 1 Demonstrated efficacy and tolerability in treating facial...Read more
Phase 3 MARIPOSA study showed LAZCLUZE® plus RYBREVANT® significantly improved progression-free survival, reducing the risk of disease progression or death by 30 per cent versus osimertinib alone.1 TORONTO, March 10, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) in combination with RYBREVANT® (amivantamab) for the...Read more
SKYRIZI is the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.1 MONTREAL, March 4, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that SKYRIZI® (risankizumab) is now available in Canada for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant...Read more
TORONTO, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the clinical team leading the upcoming investigator-led trial, titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTiAK), has received a No Objection Letter (NOL) from Health Canada to proceed with the trial. PONTiAK is a 700-patient Phase II trial (revised...Read more
Approval is based on the Phase 3 KEYNOTE-671 Trial KIRKLAND, QC, Feb. 11, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing...Read more
HALIFAX, NS / ACCESS Newswire / January 21, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received Investigational Testing Authorizations (ITAs) from Health Canada to begin clinical trials for new label claim applications of its recently Health Canada approved Multiplo® TP/HIV rapid test. These applications include use as a self-test and for non-professional administration, expanding access to testing for syphilis...Read more
Positive Reimbursement Recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux TORONTO, Jan. 20, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has provided market authorization for FRUZAQLA™ (fruquintinib capsules), indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously...Read more
Phase 3 MARIPOSA-2 study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival compared to carboplatin and pemetrexed alone.1 TORONTO, Jan. 16, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab for injection) in combination with carboplatin and pemetrexed (platinum-based...Read more
HALIFAX, NS / ACCESSWIRE / January 14, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received today the approval from Health Canada for its Reveal®Rapid G4 HIV-1/2 Test (Reveal® HIV test) for Point-of-Care (POC) use. The Reveal® HIV rapid test has achieved a sensitivity of 99.64% and a specificity of 99.71% and with it is highly suitable for health care professionals who require a fast, reliable, and high-quality...Read more
HALIFAX, NS / ACCESSWIRE / January 9, 2025 / Today, MedMira Inc. (MedMira) (TSXV:MIR) announced that its received investigational testing authorization (ITA) from Health Canada to begin clinical trials for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP), a cutting edge device that can determine active and non-active syphilis. The upcoming trials will be led by REACH Nexus at the MAP Centre for Urban Health...Read more
Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to...Read more
HALIFAX, NS / ACCESSWIRE / December 24, 2024 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received today, on December 24, 2024, the approval from Health Canada for its Multiplo® Rapid TP/HIV Test (Multiplo® TP/HIV) to be rolled out across Canada, a critical point-of-care tool to address the health crises with HIV and syphilis in Canada. The single Reveal® TP (Syphilis) approval will follow soon after this more complex...Read more
MONTREAL, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight's New Drug Submission (NDS) for Qelbree® (viloxazine extended-release capsules) has been accepted for review by Health Canada. Qelbree® is a novel nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Knight entered into an...Read more
ANN ARBOR, Mich., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk. "These submissions mark another pivotal milestone towards bringing our potentially lifesaving medications to the millions of...Read more
MONTREAL, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children. JORNAY PM™ is the first and only evening-dosed methylphenidate product...Read more
WINNIPEG, Manitoba, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) announces today that it has received Health Canada approval of its revyve™ Antimicrobial Wound Gel as a Class 2 Medical Device. This approval allows the Company to immediately start promoting and selling this product in Canada. “We are excited to bring this much needed product to Canada,” said Marc Edwards,...Read more
mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only one in single-dose pre-filled syringes Canada is the fourth jurisdiction to approve mRESVIA following approvals in the U.S., Europe, and Qatar CAMBRIDGE, MA / ACCESSWIRE / November 8, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active...Read more
MISSISSAUGA, ON, Oct. 29, 2024 /CNW/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today Health Canada approval of the BD Onclarity™ HPV Assay for human papillomavirus (HPV) testing for the use with self-collected vaginal specimens at home. Self-collected samples provide an alternative to the traditional Pap test performed by a clinician with a speculum, making...Read more
Once-daily, steroid-free foam designed to treat seborrheic dermatitis on all affected areas of the body, including hair-bearing regions such as the scalp Clinical trial data show notable improvement in signs and symptoms, with the majority of patients experiencing reduced itching, scaling and redness, common burdens associated with seborrheic dermatitis1 ZORYVE foam represents the first topical treatment for seborrheic dermatitis with...Read more
ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1 Second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage...Read more
DAYBUE is the first and only therapy approved in Canada for the treatment of Rett syndrome, a rare, neurodevelopmental disorder SAN DIEGO / Oct 16, 2024 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that Health Canada has granted marketing authorization of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process....Read more
TORONTO, Sept. 26, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has accepted for review its New Drug Submission (NDS) for vanzacaftor/tezacaftor/deutivacaftor, a once-daily triple combination therapy for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane...Read more
First regulatory authorization of a CRISPR-based gene-editing therapy in Canada TORONTO, Sept. 25, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced Health Canada has granted Marketing Authorization for PrCASGEVY® (exagamglogene autotemcel), an autologous genome edited hematopoietic stem cell-based therapy, for the treatment of patients 12 years of age and older with sickle cell disease...Read more
KIRKLAND, QC, Sept. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a...Read more
LAVAL, QC / ACCESSWIRE / September 11, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the approval by Health Canada of PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older.1 CABTREO is the first and only triple-combination...Read more
CONSTELLA is the first and only Health Canada-approved prescription therapy for functional constipation in this patient population Submission is based on positive Phase 3 study data demonstrating linaclotide (72mcg) resulted in increases in frequency of spontaneous bowel movements (SBM) in children and adolescents aged 6 to 17 years MONTREAL, Sept. 10, 2024 /CNW/ - AbbVie (NYSE: ABBV), today announced that Health Canada has approved...Read more
Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025 CAMBRIDGE, MA / ACCESSWIRE / September 9, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that its manufacturing facility in Laval, Quebec, has been granted a Drug Establishment License (DEL) from Health Canada. This certification affirms the facility's compliance with rigorous safety and quality standards, authorizing it to produce drug substance....Read more
ATLANTA, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces that it has received CE mark certification and product approval from Health Canada, the Public Health Agency of Canada, for its compact, eco-friendly FemVue®...Read more
Approval is based on the Phase 3 KEYNOTE-A39 Trial KIRKLAND, QC, Aug. 22, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate, for the treatment of adult patients with unresectable locally advanced or metastatic...Read more
Toronto, Ontario – TheNewswire - (August 21, 2024) - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTC:VPTDF) a leader in whole heart analysis, is pleased to announce that it has received a Medical Device License from Health Canada for its latest product offering, VMS+4.0. This is a major milestone for Ventripoint as it continues to innovate and provide cutting-edge solutions to cardiac clinicians...Read more
Only Automated Insulin Delivery System in Canada to Feature Both Dexcom G7 and G6 CGM Technology Now Authorized for Sale by Health Canada MARKHAM, Ontario / Jul 29, 2024 / Business Wire / Tandem Diabetes Care, Inc. (Nasdaq: TNDM) and Dexcom, Inc. (Nasdaq: DXCM) today announced the updated t:slim X2™ insulin pump software is compatible with both Dexcom G7 and Dexcom G6 Continuous Glucose Monitoring (CGM) Systems and is authorized...Read more
TORONTO, July 29, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received a medical device license issued by Health Canada to market the Venus Bliss MAX system in Canada. The Venus Bliss MAX was first available in the United States in early 2022 and subsequently offered in approved jurisdictions around the...Read more
July 16, 2024 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes (“T1D”). Health Canada has approved a Phase 2a dose confirmation study of tolimidone in T1D. The study will be an...Read more
Approximately 200 people with certain rare CF mutations are now eligible for TRIKAFTA® TORONTO, July 15, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for the expanded use of PrTRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have a mutation in the...Read more
Phase 3 PAPILLON study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival, reducing the risk of disease progression or death by 60 per cent versus carboplatin and pemetrexed alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations.1 TORONTO, July 3, 2024 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada,...Read more
Novavax's COVID-19 vaccine would be the only protein-based option available in Canada, if authorized Novavax's filing is aligned with NACI, U.S. FDA, EMA and WHO recommendations on vaccine composition GAITHERSBURG, Md., July 2, 2024 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that it has filed for authorization with Health Canada for its...Read more
The Company will ship 160 doses of MDMA and psilocybin to Australian psychiatrists for the treatment of patients with PTSD and Treatment-Resistant Depression. Vancouver, British Columbia--(Newsfile Corp. - June 25, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-approved, GMP-compliant pharmaceutical drug manufacturer specializing in the controlled substances MDMA and...Read more
HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option TORONTO, June 21, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement...Read more
VANCOUVER, BC, June 3, 2024 /CNW/ - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Health Canada-licensed psychedelics pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA, is pleased to announce that it has been awarded a Drug Establishment Licence (DEL) from Health Canada for the manufacturing and sale of its MDMA and psilocybin...Read more
TORONTO, June 03, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received a medical device license issued by Health Canada to market the Venus Versa Pro system in Canada. The Venus Versa Pro is a comprehensive aesthetic platform which houses the latest technologies in one device to offer a total skin...Read more
VANCOUVER, BC, May 30, 2024 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, announces that Health Canada has approved the Company's Clinical Trial Application to examine the feasibility of a group model in MDMA-assisted psychotherapy...Read more
VAUGHAN, Ontario / May 28, 2024 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that Health Canada has approved the enVista® Envy™* full visual range intraocular lens (IOL). This is the first global regulatory approval of the new lens, which offers a full range of vision with excellent dysphotopsia tolerance on the widely...Read more
Approval is based on the Phase 3 KEYNOTE-966 Trial KIRKLAND, QC, May 9, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with gemcitabine-based chemotherapy, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract...Read more
QULIPTA is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent migraine across all frequencies, including episodic and chronic. Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval was based on a pivotal Phase 3 clinical trial that...Read more
SAN DIEGO / Apr 22, 2024 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that Health Canada has accepted its New Drug Submission (NDS) for trofinetide for the treatment of Rett syndrome, a rare neurodevelopmental disorder. Health Canada has granted Priority Review for Acadia’s submission. “Rett syndrome is a profoundly debilitating and complex neurodevelopmental disorder that presents differently across...Read more
NEW YORK, NY / ACCESSWIRE / April 19, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product. Nora Pharma has received approval from Health Canada for the...Read more
Approval is based on the Phase 3 KEYNOTE-859 Trial KIRKLAND, QC, April 19, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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