Regulatory ApprovalsCorcept Submits NDA for Relacorilant in Platinum-Resistant Ovarian Cancer
Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, in combinat...
Regulatory Approval
Regulatory Approvals
Regulatory ApprovalsCaranx Medical Receives FDA Clearance for AI-Powered Software Guiding Transcatheter Heart Valve Implantation
Caranx Medical announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter aorti...
Regulatory ApprovalsSun Pharma Launches LEQSELVI™ (deuruxolitinib) for Severe Alopecia Areata in the U.S.
Sun Pharma announced the launch of LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. LEQSELVI ...
Regulatory ApprovalsFDA Grants Fast Track Designation to Zenith's ZEN-3694 for NUT Carcinoma
Zenith Epigenetics announced that the FDA granted Fast Track designation to ZEN-3694, in combination with abemaciclib, for treating metastatic or unre...
Regulatory ApprovalsFDA Rejects Ultragenyx's Gene Therapy for Sanfilippo Syndrome Due to Manufacturing Issues
Ultragenyx's investigational gene therapy, UX111, for Sanfilippo syndrome type A, was rejected by the FDA due to manufacturing concerns. The FDA's co...
Regulatory ApprovalsEMA Lifts Restriction on Valneva's Chikungunya Vaccine IXCHIQ® for Elderly Patients
Valneva announced that the European Medicines Agency (EMA) has lifted the temporary restriction on using its single-dose chikungunya vaccine, IXCHIQ®,...
Regulatory ApprovalsZevra Therapeutics Announces Presentations on MIPLYFFA® (arimoclomol) at Niemann-Pick Disease Conference
Zevra Therapeutics announced that MIPLYFFA® (arimoclomol), the first FDA-approved treatment for Niemann-Pick disease type C (NPC), will be featured in...
Regulatory ApprovalsFDA Approves KERENDIA® (finerenone) for Heart Failure with LVEF ≥40%
The U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) to treat heart failure (HF) with left ventricular ejection fraction (L...
Regulatory ApprovalsFDA Grants Orphan Drug Designation to JR-446 for Mucopolysaccharidosis Type IIIB
The U.S. Food and Drug Administration (FDA) granted orphan drug designation to JR-446, a drug developed by MEDIPAL HOLDINGS CORPORATION and JCR Pharma...
Regulatory ApprovalsAktiia's Hilo Band: First Cuffless Blood Pressure Monitor Approved for OTC Use by FDA
Aktiia announced FDA 510(k) clearance for its cuffless blood pressure monitoring technology, marketed as the Hilo Band. This marks the first FDA clea...
Regulatory ApprovalsFDA Approves Insightec's Exablate Neuro for Staged Bilateral Treatment of Parkinson's Disease
Insightec announced FDA approval of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson's ...
Regulatory ApprovalsNovartis Receives Approval for First Malaria Medicine for Newborns and Young Infants
Novartis announced that Coartem® (artemether-lumefantrine) Baby, also known as Riamet® Baby, has received approval from Swissmedic as the first malari...
Regulatory ApprovalsEmpNia Receives FDA Clearance for eMotus™ Respiratory Motion Management System
EmpNia Inc. announced FDA clearance for its eMotus™ system, a disposable sensor pad and software for managing respiratory motion in image-guided radia...
Regulatory ApprovalsChina Approves HUTCHMED's ORPATHYS® and TAGRISSO® Combination for Lung Cancer
HUTCHMED announced that the China National Medical Products Administration (NMPA) approved the combination of ORPATHYS® (savolitinib) and TAGRISSO® (o...
Regulatory ApprovalsFDA Grants Priority Review to Syndax's Revuforj® (revumenib) for Relapsed/Refractory mNPM1 AML
Syndax Pharmaceuticals announced that the FDA granted Priority Review to its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to tre...
Regulatory ApprovalsFDA Grants RMAT Designation to enGene's Detalimogene for High-Risk Bladder Cancer
enGene Holdings Inc. announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, det...
Regulatory ApprovalsDupixent Approved for Bullous Pemphigoid
The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, and rare skin disease. T...
Regulatory ApprovalsZemcelpro® Receives Positive CHMP Opinion for Blood Cancer Treatment
ExCellThera announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opin...
Regulatory ApprovalsMadrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra) for MASH
Madrigal Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinio...
Regulatory ApprovalsRelief Therapeutics' RLF-TD011 Denied QIDP Designation but Remains on Track for EB Treatment
Relief Therapeutics announced that its RLF-TD011, a hypochlorous acid solution for epidermolysis bullosa (EB), was not granted Qualified Infectious Di...
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