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Mar 15, 2023, 08:00 ET Medtronic receives CE Mark approval for Affera™ Mapping and Ablation System to treat atrial arrhythmias

Medtronic (NYSE:MDT) announced today that it has received CE (Conformité Européenne) Mark for the Affera™ Mapping and Ablation System, which includes ...

Mar 15, 2023, 07:00 ET Cepheid Receives Health Canada Licence for Xpert® Xpress CoV-2 plus

Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® Xpress CoV-2 plus, a rapid molecular diagnostic...

Feb 28, 2023, 08:07 ET Natco Pharma (Canada) Inc. announces the launch of PrNAT-POMALIDOMIDE Capsules, the first generic alternative to POMALYST® in Canada

PrNAT-POMALIDOMIDE provides an affordable treatment option for patients with multiple myeloma whose disease has progressed despite initial treatments ...

Feb 21, 2023, 09:42 ET Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO® (selinexor) in Combination with Bortezomib and Dexamethasone for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group...

Feb 21, 2023, 01:00 ET Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been enrolled in...

Feb 16, 2023, 01:00 ET Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency's (EMA)...

Feb 13, 2023, 00:05 ET Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus...

Jan 19, 2023, 07:00 ET Celltrion Healthcare announces Canadian approval of Vegzelma® (bevacizumab for injection) for the treatment of five types of cancer

Vegzelma®, a bevacizumab biosimilar of Avastin®, is now approved by Health Canada Vegzelma® offers Canadian patients living with one of five types of ...

Jan 18, 2023, 12:41 ET RADICAVA® (EDARAVONE) ORAL SUSPENSION RECEIVES POSITIVE RECOMMENDATION FROM CADTH FOR THE TREATMENT OF PATIENTS WITH ALS

TORONTO, Jan. 18, 2023 /CNW/ - Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) is...

Jan 17, 2023, 07:00 ET Ultomiris® approved in Canada for adults with generalized myasthenia gravis (gMG)

First and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalized myasthenia gravis Ultomiris...

Dec 22, 2022, 07:41 ET REDUVO™ Marketing Approval on the Right Path

Second Clarifax received from Health Canada. MONTREAL, Dec. 22, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB:...

Dec 09, 2022, 12:23 ET Health Canada authorizes the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent-adapted COVID-19 booster for children 5 to 11 years of age

OTTAWA, ON, Dec. 9, 2022 /CNW/ - Today, Health Canada authorized the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent-adapted booster for use in...

Dec 07, 2022, 09:25 ET Novavax Nuvaxovid COVID-19 Vaccine Approved in Canada for Use as a Primary Series in Adolescents

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Nov 28, 2022, 08:03 ET Health Canada Has Approved (Pr)SOTYKTU™ (deucravacitinib tablets), an Oral Treatment for Adults with Moderate to Severe Plaque Psoriasis

SOTYKTU is the first and only approved TYK2 inhibitor in Canada and represents an important milestone in oral treatment for moderate to severe plaque ...

Nov 18, 2022, 08:08 ET Novavax Nuvaxovid COVID-19 Vaccine Receives Expanded Authorization in Canada as a Booster in Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Nov 17, 2022, 09:00 ET See-Mode Technologies Receives Health Canada Approval for AI Software that Automatically Analyses and Reports Breast & Thyroid Ultrasound Scans

See-Mode Technologies, a MedTech company based in Australia that is on a mission to unlock the hidden insights within medical imaging, today...

Nov 07, 2022, 07:30 ET Organon Canada launches Aybintio®, a biosimilar of the reference biologic Avastin®, providing a new option at a reduced cost for Canadians living with certain aggressive forms of cancer

KIRKLAND, QC, Nov. 7, 2022 /CNW/ - Organon (NYSE: OGN), a global women's health company, is announcing the launch and product availability of...

Oct 28, 2022, 01:00 ET Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation...

Oct 26, 2022, 16:30 ET Health Canada approves KERENDIA® (finerenone) as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D)

Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular...

Oct 19, 2022, 08:30 ET Medtronic expands global access to the benefits of robotic-assisted surgery

Medtronic plc (NYSE:MDT), a global healthcare technology leader, has announced three significant global market-entrance and indication expansion...

Oct 17, 2022, 08:17 ET SQI Diagnostics Announces Health Canada Approval of RALI-Dx Severity Triage Test

TORONTO, Oct. 17, 2022 /CNW/ - SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF), a leader in the science of lung health that develops and manufactures ...

Oct 13, 2022, 20:13 ET Health Canada Approves Illuccix® for Prostate Cancer Imaging

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that Health Canada has approved Illuccix® [kit for the preparation of gallium...

Oct 12, 2022, 12:30 ET Vitacore Receives NIOSH Approval for BC-Made CAN99 9500 Respirators

Leading Canadian PPE manufacturer gains first respirator approval from the world's foremost health and safety authority VANCOUVER, BC, Oct. 12, 2022...

Oct 11, 2022, 01:00 ET Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has submitted a Marketing Authorisation...

Oct 07, 2022, 11:00 ET Pfizer and BioNTech's Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster Receives Health Canada Authorization for Individuals 12 Years of Age and Older

COMIRNATY Original & Omicron BA.4/BA.5 now authorized in Canada as a booster dose for individuals 12 years of age and older Authorization is based on ...