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Priority Review

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention,…

Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA)…

Everest Medicines Announces China NMPA’s Approval of Nefecon® for the Treatment of Primary IgA Nephropathy in Adult Patients USA – English 

Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that China’s National Medical Products Administration (NMPA) has approved Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN)…

New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy USA – English 

Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that its commercial partner Everest Medicines (HKEX 1952.HK) (“Everest”) received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China. The approval for Nefecon is for the treatment of primary immunoglobulin…