Health Canada Approval

Canadian mental healthcare biopharma company Apex Labs, Ltd. received approval for its new US-based supplier of Good Manufacturing Practices (GMP)-compliant psilocybin Active Pharmaceutical Ingredient (API.) The company is currently conducting several large-scale, “...

Psychedelics research and manufacturing company Optimi Health Corp. (OTCQX: OPTHF) received a “Natural Health Product Site" license, adding to its existing permits to produce and supply psychedelic substances including MDMA and psilocybin. See also: Another Company...

Wellbeing Digital (OTC: KONEF) subsidiary KGK Sciences will advance with the first-ever Phase 2a clinical trial assessing repetitive, oral microdose psilocybin therapy for Fragile X Syndrome (FXS), a genetic disorder. KGK and its client Nova Mentis (OTC: NMLSF) are set to conduct this pioneering...

Psychedelic-assisted therapy provider, Numinus Wellness Inc. (OTCQX: NUMIF) received Health Canada’s approval for its experiential training study, which will assess both the safety and clinical efficacy of whole magic mushrooms tea as well as enable practitioners to expand their understanding...

Health Canada Oks Clinical-Grade MDMA Export To UK Life sciences psychedelics company PharmAla Biotech Holdings Inc. and its manufacturing partners received a Health Canada export permit for no less than 300 grams of proprietary MDMA LaNeo. “We’re incredibly proud of this milestone. It...

Let’s do a quick tour of some of the latest announcements made by psychedelics companies over the past week. We promise you’ll be informed in less time than it takes to brew your coffee. New, Standardized Magic Mushroom Microdosing Capsules By Red Light Holland And Partner...

The partnership leading the way on psilocybin therapy for Fragile X Syndrome (FXS), the major genetic cause of Autism Spectrum Disorder (ASD), has received approval from Health Canada in the form of a No Objection letter and is set to proceed with the first-ever Phase 2a clinical trial on the magic...

Psychedelics biotechs Nova Mentis Life Science Corp. (OTCQB: NMLSF) and Wellbeing Digital Sciences Inc. (OTC: KONEF)’s subsidiary KGK Sciences Inc. have submitted the first-ever Phase 2a Clinical Trial Application (CTA) to test safety and efficacy of oral microdose of proprietary psilocybin...

Canadian-based psychedelics company Nova Mentis Life Science Corp. (OTCQB: NMLSF), or NOVA, is collaborating with the Toronto Institute of Pharmaceutical Technology (TIPT), a Health Canada-licensed GMP manufacturing and testing facility, to complete the production of an engineering...

Health Canada has granted approval for Merck’s (NYSE: MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.  The regulatory approval is based on the data readout from...

Health Canada announced approval for Bristol Myers Squibb’s (NASDAQ: BMY) OPDIVO (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles in adult patients with resectable non-small cell lung cancer (...