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
Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review TORONTO, April 1, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission (NDS) for exagamglogene autotemcel (exa-cel) has been accepted for Priority Review by Health Canada for the treatment of patients aged 12 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive...Read more
ELYXYB® is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1 According to market data from 2018, it was found that migraine was more severe than other types of headaches and it impacted more than 2.7 million Canadians with the Canadian migraine therapeutics market estimated to reach approximately $400 million by 2025.2 There is strong...Read more
Aiding in the diagnosis of preterm pre-eclampsia and prognosis of delivery in symptomatic women SAN DIEGO / Mar 06, 2024 / Business Wire / QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada. The...Read more
Well Positioned to Enter US $1.56 Billion Canadian Cardiology Devices Market REDWOOD CITY, CA / ACCESSWIRE / February 29, 2024 / Biotricity Inc. (NASDAQ:BTCY) ("Biotricity" or the "Company"), a leading medical diagnostic and consumer healthcare technology company, proudly announced its Health Canada approval for expansion into the US$1.56 billion Canadian Cardiology Devices market. Cardiovascular disease imposes a staggering US$21.2...Read more
Approval is based on the Phase 3 KEYNOTE-811 Trial KIRKLAND, QC, Feb. 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, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced...Read more
BRUKINSA is the first and only BTK inhibitor approved for follicular lymphoma in Canada Follicular lymphoma (FL) is the 2nd most common type of non-Hodgkin lymphoma (NHL) This is the fifth Canadian therapeutic indication for BRUKINSA TORONTO, Feb. 7, 2024 /CNW/ - BeiGene, Ltd. (Nasdaq: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company, today announced it received Health Canada authorization for the use of BRUKINSA®...Read more
HALIFAX, NS / ACCESSWIRE / February 1, 2024 / Today, MedMira Inc. (MedMira) (TSXV:MIR) is pleased to provide an update on the ongoing review process by Health Canada. The Company made the required submission and has been working towards extending its intended use highlighting the increasing need in maternity screening. MedMira is committed to provide the fastest and most accurate solution to the increasing infection rates for infectious...Read more
TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating...Read more
Topical terbinafine has been widely used in other markets to treat fungal nail infections If and when approved, the product will enter the topical fungicides market that is estimated to be C$88 million on an annual basis* Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 8, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that Health Canada recently accepted for review Medexus's new drug...Read more
VANCOUVER, British Columbia, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”), a Health Canada licensed drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, proudly announces a significant milestone in the granting of its Precursor Licence for 3,4-Methylenedioxyphenyl-2-propanone (“MDP2P”), the precursor used in the...Read more
NKGen’s SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada for a phase 1/2a clinical trial in moderate Alzheimer’s Disease patients Based on data generated from its Phase I dose escalation safety trial, presented at the recent CTAD conference in October 2023, NKGen is optimistic that the Phase 1/2a clinical trial could demonstrate more...Read more
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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