Regulatory Approvals
Page 1 • 11 itemsTrack global regulatory approvals for new drugs and biologics. Stay ahead in pharma BD with critical FDA, EMA, and PMDA insights.
CRISPR Therapeutics Reports Q1 2026 Results as CASGEVY Gene Therapy Gains Global Regulatory Approval
CRISPR Therapeutics reports Q1 2026 financial results highlighting CASGEVY's approval in 10+ countries for sickle cell disease and beta thalassemia treatment.
FDA Approves Auvelity for MDD: Axsome Therapeutics Scores Win
The U.S. Food and Drug Administration (FDA) has approved Auvelity, a novel oral antidepressant developed by Axsome Therapeutics, for the treatment of Major Depressive Disorder (MDD) in adults. This approval represents a significant advancement in the mental health landscape.
Auvelity FDA Approval: New Hope for MDD Patients
The FDA has approved Auvelity, a groundbreaking oral antidepressant from Axsome Therapeutics, marking a significant advancement in treating major depressive disorder (MDD). This approval introduces a novel mechanism of action for patients seeking effective relief.
Orchard Therapeutics OTL-201: Innovation Passport for MPS-IIIA
Orchard Therapeutics has secured an Innovation Passport designation from the MHRA for its investigational gene therapy, OTL-201, targeting MPS-IIIA. This marks a significant step in accelerating development and access for patients with Sanfilippo syndrome type A.
FDA Approves Auvelity for MDD: Axsome Therapeutics' New Antidepressant
The FDA has granted approval for Auvelity, a new oral antidepressant developed by Axsome Therapeutics, to treat major depressive disorder (MDD) in adults. This marks a significant advancement in mental health treatment, offering a novel mechanism of action and potentially rapid symptom relief.
Auvelity FDA Approval: A New MDD Treatment Option
The FDA has approved Auvelity, a novel oral therapy from Axsome Therapeutics, for the treatment of major depressive disorder (MDD). This marks a significant advancement in MDD treatment options.
Plozasiran TGA Approval in Australia for FCS Patients
Arrowhead Pharmaceuticals has announced the Therapeutic Goods Administration (TGA) approval of REDEMPLO® (plozasiran) in Australia for patients with Familial Chylomicronemia Syndrome (FCS). This landmark decision broadens global access to a crucial treatment for this rare genetic disorder.
X4 Pharmaceuticals Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment in EU
X4 Pharmaceuticals announces European Commission approval for XOLREMDI (mavorixafor), the first authorized treatment for WHIM syndrome patients in the EU.
Mauna Kea Technologies Secures CE Mark Under New MDR, Expands European Medical Device Approvals
Mauna Kea Technologies obtains CE Mark under new Medical Device Regulation and regulatory approvals in UK and Switzerland, marking significant expansion.
Biocon Receives Health Canada Approval for Denosumab Biosimilars Bosaya and Vevzuo
Health Canada approves Biocon's denosumab biosimilars Bosaya and Vevzuo as alternatives to Prolia and Xgeva for osteoporosis and cancer treatment.
Bavarian Nordic's VIMKUNYA Chikungunya Vaccine Receives First Swiss Approval from Swissmedic
Bavarian Nordic receives Swissmedic approval for VIMKUNYA, the first chikungunya vaccine approved in Switzerland for individuals 12 years and older.